Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2026-03-09 @ 2:44 AM
Study NCT ID:
NCT04090060
Status:
COMPLETED
Last Update Posted:
2024-07-09
First Post:
2019-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Prevent Anal Cancer Palpation Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001005', 'term': 'Anus Neoplasms'}], 'ancestors': [{'id': 'D012004', 'term': 'Rectal Neoplasms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D001004', 'term': 'Anus Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'anyitray@mcw.edu', 'phone': '414-955-7701', 'title': 'Alan Nyitray, PhD', 'organization': 'Medical college of Wisconsin'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '180 days', 'eventGroups': [{'id': 'EG000', 'title': 'Practice Self-/Companion Exams', 'description': '300 individuals and 50 couples will be randomized to practice arm.\n\nPractice Self-/Companion Exams: 300 men and 50 couples will be randomized and encouraged to practice anal exams at home before Visit 2. Practice results will be elicited by staff. They will return for Visit 2 (six months after Visit 1). At Visit 2, they will complete a pre- and post-visit computer assisted self-interview. They will receive written instructions. After completing an anal self-exam or anal companion exam at home, they will record the results. At the clinic, they will have a Digital Anal Rectal Exam (DARE) by a clinician who will give the subject his results.', 'otherNumAtRisk': 359, 'deathsNumAtRisk': 359, 'otherNumAffected': 0, 'seriousNumAtRisk': 359, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Arm', 'description': '300 individuals and 50 couples will neither be encouraged nor discouraged to practice self-/companion exam.\n\nControl Arm: 300 individuals and 50 couples will be randomized to this arm. Following Visit 1, they will neither be encouraged nor discouraged from practicing self- or companion exam. They will return for Visit 2 (six months after Visit 1). They will receive written anal exam instructions. They will then complete the self- or companion exam at home, and record the results. At the clinic, they will receive a clinician DARE. Clinicians will give DARE results. Persons will take a post-exam computer-assisted self-interview. Persons in this arm (control) will be asked if they have performed exams between visits.', 'otherNumAtRisk': 359, 'deathsNumAtRisk': 359, 'otherNumAffected': 0, 'seriousNumAtRisk': 359, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Concordance Between Self-examination and Clinician Examination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '331', 'groupId': 'OG000'}, {'value': '327', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Practice Self-/Companion Exams', 'description': '300 individuals and 50 couples will be randomized to practice arm.\n\nPractice Self-/Companion Exams: 300 individuals and 50 couples will be randomized and encouraged to practice anal exams at home before Visit 2. Practice results will be elicited by staff. They will return for Visit 2 (six months after Visit 1). At Visit 2, they will complete a pre- and post-visit computer assisted self-interview. They will receive written instructions. After completing an anal self-exam or anal companion exam at home, they will record the results. At the clinic, they will have a Digital Anal Rectal Exam (DARE) by a clinician who will give the subject his results.'}, {'id': 'OG001', 'title': 'Control Arm', 'description': '300 individuals and 50 couples will neither be encouraged nor discouraged to practice self-/companion exam.\n\nControl Arm: 300 individuals and 50 couples will be randomized to this arm. Following Visit 1, they will neither be encouraged nor discouraged from practicing self- or companion exam. They will return for Visit 2 (six months after Visit 1). They will receive written anal exam instructions. They will then complete the self- or companion exam at home, and record the results. At the clinic, they will receive a clinician DARE. Clinicians will give DARE results. Persons will take a post-exam computer-assisted self-interview. Persons in this arm (control) will be asked if they have performed exams between visits.'}], 'classes': [{'categories': [{'measurements': [{'value': '234', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1', 'description': 'This measure will record the number of concordant digital anal examination results. A concordant result means that the subject and clinician agree as to the presence or absence of an abnormality.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Of 718 individuals, outcome results were available for 714 individuals with two participants in the Practice Self/Companion Exams arm and two participants in the Control Arm not completing the self-/companion examination or not completing a digital anal rectal examination. Of the 714, 357 were in the practice arm and 357 in the control arm. Of the 714, 658 completed a self-exam and 56 completed a companion exam.'}, {'type': 'PRIMARY', 'title': 'Concordance Between Self-examination and Clinician Examination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '261', 'groupId': 'OG000'}, {'value': '255', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Practice Self-/Companion Exams', 'description': '300 individuals and 50 couples will be randomized to practice arm.\n\nPractice Self-/Companion Exams: 300 individuals and 50 couples will be randomized and encouraged to practice anal exams at home before Visit 2. Practice results will be elicited by staff. They will return for Visit 2 (six months after Visit 1). At Visit 2, they will complete a pre- and post-visit computer assisted self-interview. They will receive written instructions. After completing an anal self-exam or anal companion exam at home, they will record the results. At the clinic, they will have a Digital Anal Rectal Exam (DARE) by a clinician who will give the subject his results.'}, {'id': 'OG001', 'title': 'Control Arm', 'description': '300 individuals and 50 couples will neither be encouraged nor discouraged to practice self-/companion exam.\n\nControl Arm: 300 individuals and 50 couples will be randomized to this arm. Following Visit 1, they will neither be encouraged nor discouraged from practicing self- or companion exam. They will return for Visit 2 (six months after Visit 1). They will receive written anal exam instructions. They will then complete the self- or companion exam at home, and record the results. At the clinic, they will receive a clinician DARE. Clinicians will give DARE results. Persons will take a post-exam computer-assisted self-interview. Persons in this arm (control) will be asked if they have performed exams between visits.'}], 'classes': [{'categories': [{'measurements': [{'value': '248', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 180.', 'description': 'This measure will record the number of concordant digital anal examination results. A concordant result means that the subject and clinician agree as to the presence or absence of an abnormality.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Seventy of 331 participants in the Practice Self-Companion Exams arm and 72 of 327 participants in the control arm completing a baseline examination (Outcome Measure 1) did not complete an examination at 180 days.'}, {'type': 'PRIMARY', 'title': 'Concordance Between Companion Examination and Clinician Examination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Practice Self-/Companion Exams', 'description': '300 individuals and 50 couples will be randomized to practice arm.\n\nPractice Self-/Companion Exams: 300 individuals and 50 couples will be randomized and encouraged to practice anal exams at home before Visit 2. Practice results will be elicited by staff. They will return for Visit 2 (six months after Visit 1). At Visit 2, they will complete a pre- and post-visit computer assisted self-interview. They will receive written instructions. After completing an anal self-exam or anal companion exam at home, they will record the results. At the clinic, they will have a Digital Anal Rectal Exam (DARE) by a clinician who will give the subject his results.'}, {'id': 'OG001', 'title': 'Control Arm', 'description': '300 individuals and 50 couples will neither be encouraged nor discouraged to practice self-/companion exam.\n\nControl Arm: 300 individuals and 50 couples will be randomized to this arm. Following Visit 1, they will neither be encouraged nor discouraged from practicing self- or companion exam. They will return for Visit 2 (six months after Visit 1). They will receive written anal exam instructions. They will then complete the self- or companion exam at home, and record the results. At the clinic, they will receive a clinician DARE. Clinicians will give DARE results. Persons will take a post-exam computer-assisted self-interview. Persons in this arm (control) will be asked if they have performed exams between visits.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1', 'description': "This measure will record the number of concordant digital anal examination results. A concordant result means that the subject's companion and clinician agree as to the presence or absence of an abnormality.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The unit of analysis is the individual and not the couple.'}, {'type': 'PRIMARY', 'title': 'Concordance Between Companion Examination and Clinician Examination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Practice Self-/Companion Exams', 'description': '300 individuals and 50 couples will be randomized to practice arm.\n\nPractice Self-/Companion Exams: 300 individuals and 50 couples will be randomized and encouraged to practice anal exams at home before Visit 2. Practice results will be elicited by staff. They will return for Visit 2 (six months after Visit 1). At Visit 2, they will complete a pre- and post-visit computer assisted self-interview. They will receive written instructions. After completing an anal self-exam or anal companion exam at home, they will record the results. At the clinic, they will have a Digital Anal Rectal Exam (DARE) by a clinician who will give the subject his results.'}, {'id': 'OG001', 'title': 'Control Arm', 'description': '300 individuals and 50 couples will neither be encouraged nor discouraged to practice self-/companion exam.\n\nControl Arm: 300 individuals and 50 couples will be randomized to this arm. Following Visit 1, they will neither be encouraged nor discouraged from practicing self- or companion exam. They will return for Visit 2 (six months after Visit 1). They will receive written anal exam instructions. They will then complete the self- or companion exam at home, and record the results. At the clinic, they will receive a clinician DARE. Clinicians will give DARE results. Persons will take a post-exam computer-assisted self-interview. Persons in this arm (control) will be asked if they have performed exams between visits.'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 180', 'description': "This measure will record the number of concordant digital anal examination results. A concordant result means that the subject's companion and clinician agree as to the presence or absence of an abnormality.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Twenty of twenty-six participants in the Practice Self-/Companion Exams arm and twenty-six of thirty participants in the Control Arm completed companion examinations at 180 days.'}, {'type': 'PRIMARY', 'title': 'Number of Persons Who Practice the Self Examination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '331', 'groupId': 'OG000'}, {'value': '327', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Practice Self-/Companion Exams', 'description': '300 individuals and 50 couples will be randomized to practice arm.\n\nPractice Self-/Companion Exams: 300 individuals and 50 couples will be randomized and encouraged to practice anal exams at home before Visit 2. Practice results will be elicited by staff. They will return for Visit 2 (six months after Visit 1). At Visit 2, they will complete a pre- and post-visit computer assisted self-interview. They will receive written instructions. After completing an anal self-exam or anal companion exam at home, they will record the results. At the clinic, they will have a Digital Anal Rectal Exam (DARE) by a clinician who will give the subject his results.'}, {'id': 'OG001', 'title': 'Control Arm', 'description': '300 individuals and 50 couples will neither be encouraged nor discouraged to practice self-/companion exam.\n\nControl Arm: 300 individuals and 50 couples will be randomized to this arm. Following Visit 1, they will neither be encouraged nor discouraged from practicing self- or companion exam. They will return for Visit 2 (six months after Visit 1). They will receive written anal exam instructions. They will then complete the self- or companion exam at home, and record the results. At the clinic, they will receive a clinician DARE. Clinicians will give DARE results. Persons will take a post-exam computer-assisted self-interview. Persons in this arm (control) will be asked if they have performed exams between visits.'}], 'classes': [{'categories': [{'measurements': [{'value': '261', 'groupId': 'OG000'}, {'value': '255', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 180', 'description': 'This measure will count the number of subjects who practiced the self examination at least one time between days 1 and 180.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All units of data are unique individuals and not couples.'}, {'type': 'PRIMARY', 'title': 'Number of Persons Who Practice the Companion Examination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Practice Self-/Companion Exams', 'description': '300 individuals and 50 couples will be randomized to practice arm.\n\nPractice Self-/Companion Exams: 300 men and 50 couples will be randomized and encouraged to practice anal exams at home before Visit 2. Practice results will be elicited by staff. They will return for Visit 2 (six months after Visit 1). At Visit 2, they will complete a pre- and post-visit computer assisted self-interview. They will receive written instructions. After completing an anal self-exam or anal companion exam at home, they will record the results. At the clinic, they will have a Digital Anal Rectal Exam (DARE) by a clinician who will give the subject his results.\n\nThus the Overall Number of Baseline Participants, Overall number of Participants Analyzed and Number of Participants at Risk reflect a unique number of participants and NOT a combination of participants and dyads.'}, {'id': 'OG001', 'title': 'Control Arm', 'description': '300 individuals and 50 couples will neither be encouraged nor discouraged to practice self-/companion exam.\n\nControl Arm: 300 individuals and 50 couples will be randomized to this arm. Following Visit 1, they will neither be encouraged nor discouraged from practicing self- or companion exam. They will return for Visit 2 (six months after Visit 1). They will receive written anal exam instructions. They will then complete the self- or companion exam at home, and record the results. At the clinic, they will receive a clinician DARE. Clinicians will give DARE results. Persons will take a post-exam computer-assisted self-interview. Persons in this arm (control) will be asked if they have performed exams between visits.\n\nThe Overall Number of Baseline Participants, Overall number of Participants Analyzed and Number of Participants at Risk reflect a unique number of participants and NOT a combination of participants and dyads.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 180', 'description': 'This measure will count the number of subjects who practiced the companion examination at least one time between days 1 and 180.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The unit of analysis is the individual not the dyad (or couple).'}, {'type': 'SECONDARY', 'title': 'Measuring the Difference Between Chicago and Houston Self-exam Concordance.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '331', 'groupId': 'OG000'}, {'value': '327', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Practice Self-/Companion Exams', 'description': '300 individuals and 50 couples will be randomized to practice arm.\n\nPractice Self-/Companion Exams: 300 men and 50 couples will be randomized and encouraged to practice anal exams at home before Visit 2. Practice results will be elicited by staff. They will return for Visit 2 (six months after Visit 1). At Visit 2, they will complete a pre- and post-visit computer assisted self-interview. They will receive written instructions. After completing an anal self-exam or anal companion exam at home, they will record the results. At the clinic, they will have a Digital Anal Rectal Exam (DARE) by a clinician who will give the subject his results.'}, {'id': 'OG001', 'title': 'Control Arm', 'description': '300 individuals and 50 couples will neither be encouraged nor discouraged to practice self-/companion exam.\n\nControl Arm: 300 individuals and 50 couples will be randomized to this arm. Following Visit 1, they will neither be encouraged nor discouraged from practicing self- or companion exam. They will return for Visit 2 (six months after Visit 1). They will receive written anal exam instructions. They will then complete the self- or companion exam at home, and record the results. At the clinic, they will receive a clinician DARE. Clinicians will give DARE results. Persons will take a post-exam computer-assisted self-interview. Persons in this arm (control) will be asked if they have performed exams between visits.'}], 'classes': [{'title': 'Chicago', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '127', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}]}, {'title': 'Houston', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '107', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1', 'description': 'This measure will count the number of subjects in outcome measures 1, 2, 5 and 9 comparing subjects living in the Chicago and Houston metropolitan areas.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This measure involves only the participants living in either the Chicago or Houston metropolitan areas.'}, {'type': 'SECONDARY', 'title': 'Measuring the Difference Between Chicago and Houston Companion Exam Concordance.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Practice Self-/Companion Exams', 'description': '300 individuals and 50 couples will be randomized to practice arm.\n\nPractice Self-/Companion Exams: 300 men and 50 couples will be randomized and encouraged to practice anal exams at home before Visit 2. Practice results will be elicited by staff. They will return for Visit 2 (six months after Visit 1). At Visit 2, they will complete a pre- and post-visit computer assisted self-interview. They will receive written instructions. After completing an anal self-exam or anal companion exam at home, they will record the results. At the clinic, they will have a Digital Anal Rectal Exam (DARE) by a clinician who will give the subject his results.'}, {'id': 'OG001', 'title': 'Control Arm', 'description': '300 individuals and 50 couples will neither be encouraged nor discouraged to practice self-/companion exam.\n\nControl Arm: 300 individuals and 50 couples will be randomized to this arm. Following Visit 1, they will neither be encouraged nor discouraged from practicing self- or companion exam. They will return for Visit 2 (six months after Visit 1). They will receive written anal exam instructions. They will then complete the self- or companion exam at home, and record the results. At the clinic, they will receive a clinician DARE. Clinicians will give DARE results. Persons will take a post-exam computer-assisted self-interview. Persons in this arm (control) will be asked if they have performed exams between visits.'}], 'classes': [{'title': 'Chicago', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Houston', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1', 'description': 'This measure will count the number of subjects in outcome measures 3, 4, 6 and 9 comparing companions living in the Chicago and Houston metropolitan areas.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This measure involves only the participants living in either the Chicago or Houston metropolitan areas who conducted companion examinations.'}, {'type': 'SECONDARY', 'title': 'Waist Circumference for Persons Doing Self-examinations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'OG000'}, {'value': '325', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Practice Self-/Companion Exams', 'description': '300 individuals and 50 couples will be randomized to practice arm.\n\nPractice Self-/Companion Exams: 300 men and 50 couples will be randomized and encouraged to practice anal exams at home before Visit 2. Practice results will be elicited by staff. They will return for Visit 2 (six months after Visit 1). At Visit 2, they will complete a pre- and post-visit computer assisted self-interview. They will receive written instructions. After completing an anal self-exam or anal companion exam at home, they will record the results. At the clinic, they will have a Digital Anal Rectal Exam (DARE) by a clinician who will give the subject his results.'}, {'id': 'OG001', 'title': 'Control Arm', 'description': '300 individuals and 50 couples will neither be encouraged nor discouraged to practice self-/companion exam.\n\nControl Arm: 300 individuals and 50 couples will be randomized to this arm. Following Visit 1, they will neither be encouraged nor discouraged from practicing self- or companion exam. They will return for Visit 2 (six months after Visit 1). They will receive written anal exam instructions. They will then complete the self- or companion exam at home, and record the results. At the clinic, they will receive a clinician DARE. Clinicians will give DARE results. Persons will take a post-exam computer-assisted self-interview. Persons in this arm (control) will be asked if they have performed exams between visits.'}], 'classes': [{'categories': [{'measurements': [{'value': '96.1', 'groupId': 'OG000', 'lowerLimit': '66.0', 'upperLimit': '171.2'}, {'value': '95.3', 'groupId': 'OG001', 'lowerLimit': '66.6', 'upperLimit': '178.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1', 'description': 'This measure will record subject waist circumference in cm.', 'unitOfMeasure': 'centimeter', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Waist circumference was not measured for 2 individuals in the practice arm and 2 individuals in the control arm.'}, {'type': 'SECONDARY', 'title': 'Concordance Between Self-examination and Clinician Examination Stratified by Waist Circumference.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'OG000'}, {'value': '325', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Practice Self-/Companion Exams', 'description': '300 individuals and 50 couples will be randomized to practice arm.\n\nPractice Self-/Companion Exams: 300 men and 50 couples will be randomized and encouraged to practice anal exams at home before Visit 2. Practice results will be elicited by staff. They will return for Visit 2 (six months after Visit 1). At Visit 2, they will complete a pre- and post-visit computer assisted self-interview. They will receive written instructions. After completing an anal self-exam or anal companion exam at home, they will record the results. At the clinic, they will have a Digital Anal Rectal Exam (DARE) by a clinician who will give the subject his results.'}, {'id': 'OG001', 'title': 'Control Arm', 'description': '300 individuals and 50 couples will neither be encouraged nor discouraged to practice self-/companion exam.\n\nControl Arm: 300 individuals and 50 couples will be randomized to this arm. Following Visit 1, they will neither be encouraged nor discouraged from practicing self- or companion exam. They will return for Visit 2 (six months after Visit 1). They will receive written anal exam instructions. They will then complete the self- or companion exam at home, and record the results. At the clinic, they will receive a clinician DARE. Clinicians will give DARE results. Persons will take a post-exam computer-assisted self-interview. Persons in this arm (control) will be asked if they have performed exams between visits.'}], 'classes': [{'title': 'Circumference <= 102 cm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '153', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}]}]}, {'title': 'Circumference >102 cm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1', 'description': 'This measure will record the number of concordant digital anal examination results in persons with less than or equal to 102 cm waist size versus greater than 102 cm waist size. A concordant result means that the subject and clinician agree as to the presence or absence of an abnormality.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This measure involves only the participants who performed a self-examination and whose waste circumference was measured. Two participants in each arm were missing waist circumference.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Practice Self-/Companion Exams', 'description': '300 individuals and 50 couples will be randomized to practice arm.\n\nPractice Self-/Companion Exams: 300 men and 50 couples will be randomized and encouraged to practice anal exams at home before Visit 2. Practice results will be elicited by staff. They will return for Visit 2 (six months after Visit 1). At Visit 2, they will complete a pre- and post-visit computer assisted self-interview. They will receive written instructions. After completing an anal self-exam or anal companion exam at home, they will record the results. At the clinic, they will have a Digital Anal Rectal Exam (DARE) by a clinician who will give the subject his results.\n\nThus the Overall Number of Baseline Participants, Overall number of Participants Analyzed and Number of Participants at Risk reflect a unique number of participants and NOT a combination of participants and dyads.'}, {'id': 'FG001', 'title': 'Control Arm', 'description': '300 individuals and 50 couples will neither be encouraged nor discouraged to practice self-/companion exam.\n\nControl Arm: 300 individuals and 50 couples will be randomized to this arm. Following Visit 1, they will neither be encouraged nor discouraged from practicing self- or companion exam. They will return for Visit 2 (six months after Visit 1). They will receive written anal exam instructions. They will then complete the self- or companion exam at home, and record the results. At the clinic, they will receive a clinician DARE. Clinicians will give DARE results. Persons will take a post-exam computer-assisted self-interview. Persons in this arm (control) will be asked if they have performed exams between visits.\n\nThe Overall Number of Baseline Participants, Overall number of Participants Analyzed and Number of Participants at Risk reflect a unique number of participants and NOT a combination of participants and dyads.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '359'}, {'groupId': 'FG001', 'numSubjects': '359'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '283'}, {'groupId': 'FG001', 'numSubjects': '282'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '76'}, {'groupId': 'FG001', 'numSubjects': '77'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '76'}, {'groupId': 'FG001', 'numSubjects': '77'}]}]}], 'preAssignmentDetails': 'After consenting online, individuals must have attended a visit 1 where the intervention was delivered and followed by randomization into Practice or Control arms. The stated number of enrollees, 718, represents unique individuals who attended visit 1 and received the intervention regardless of the individual choosing to participate in the intervention as a single person or with a partner. The outcomes are assessed at the individual level and not couple level.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'BG000'}, {'value': '359', 'groupId': 'BG001'}, {'value': '718', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Practice Self-/Companion Exams', 'description': '300 individuals and 50 couples will be randomized to practice arm.\n\nPractice Self-/Companion Exams: 300 men and 50 couples will be randomized and encouraged to practice anal exams at home before Visit 2. Practice results will be elicited by staff. They will return for Visit 2 (six months after Visit 1). At Visit 2, they will complete a pre- and post-visit computer assisted self-interview. They will receive written instructions. After completing an anal self-exam or anal companion exam at home, they will record the results. At the clinic, they will have a Digital Anal Rectal Exam (DARE) by a clinician who will give the subject his results.'}, {'id': 'BG001', 'title': 'Control Arm', 'description': '300 individuals and 50 couples will neither be encouraged nor discouraged to practice self-/companion exam.\n\nControl Arm: 300 individuals and 50 couples will be randomized to this arm. Following Visit 1, they will neither be encouraged nor discouraged from practicing self- or companion exam. They will return for Visit 2 (six months after Visit 1). They will receive written anal exam instructions. They will then complete the self- or companion exam at home, and record the results. At the clinic, they will receive a clinician DARE. Clinicians will give DARE results. Persons will take a post-exam computer-assisted self-interview. Persons in this arm (control) will be asked if they have performed exams between visits.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '340', 'groupId': 'BG000'}, {'value': '342', 'groupId': 'BG001'}, {'value': '682', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Male', 'categories': [{'measurements': [{'value': '337', 'groupId': 'BG000'}, {'value': '338', 'groupId': 'BG001'}, {'value': '675', 'groupId': 'BG002'}]}]}, {'title': 'Female', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Trans Man', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'Trans Woman', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'Non-Binary', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Not Reported', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '164', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '266', 'groupId': 'BG000'}, {'value': '286', 'groupId': 'BG001'}, {'value': '552', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '181', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '217', 'groupId': 'BG000'}, {'value': '212', 'groupId': 'BG001'}, {'value': '429', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '359', 'groupId': 'BG000'}, {'value': '359', 'groupId': 'BG001'}, {'value': '718', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-12-20', 'size': 625676, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_002.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-06-06T10:24', 'hasProtocol': True}, {'date': '2022-05-15', 'size': 248353, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-01-31T11:07', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Subjects will be randomly assigned to groups encouraged to practice anal examination (Experimental) or not encouraged to practice anal examinations (Control).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 718}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2023-06-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-10', 'studyFirstSubmitDate': '2019-09-05', 'resultsFirstSubmitDate': '2024-05-09', 'studyFirstSubmitQcDate': '2019-09-12', 'lastUpdatePostDateStruct': {'date': '2024-07-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-06-10', 'studyFirstPostDateStruct': {'date': '2019-09-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Concordance Between Self-examination and Clinician Examination', 'timeFrame': 'Day 1', 'description': 'This measure will record the number of concordant digital anal examination results. A concordant result means that the subject and clinician agree as to the presence or absence of an abnormality.'}, {'measure': 'Concordance Between Self-examination and Clinician Examination', 'timeFrame': 'Day 180.', 'description': 'This measure will record the number of concordant digital anal examination results. A concordant result means that the subject and clinician agree as to the presence or absence of an abnormality.'}, {'measure': 'Concordance Between Companion Examination and Clinician Examination', 'timeFrame': 'Day 1', 'description': "This measure will record the number of concordant digital anal examination results. A concordant result means that the subject's companion and clinician agree as to the presence or absence of an abnormality."}, {'measure': 'Concordance Between Companion Examination and Clinician Examination', 'timeFrame': 'Day 180', 'description': "This measure will record the number of concordant digital anal examination results. A concordant result means that the subject's companion and clinician agree as to the presence or absence of an abnormality."}, {'measure': 'Number of Persons Who Practice the Self Examination', 'timeFrame': 'Day 180', 'description': 'This measure will count the number of subjects who practiced the self examination at least one time between days 1 and 180.'}, {'measure': 'Number of Persons Who Practice the Companion Examination', 'timeFrame': 'Day 180', 'description': 'This measure will count the number of subjects who practiced the companion examination at least one time between days 1 and 180.'}], 'secondaryOutcomes': [{'measure': 'Measuring the Difference Between Chicago and Houston Self-exam Concordance.', 'timeFrame': 'Day 1', 'description': 'This measure will count the number of subjects in outcome measures 1, 2, 5 and 9 comparing subjects living in the Chicago and Houston metropolitan areas.'}, {'measure': 'Measuring the Difference Between Chicago and Houston Companion Exam Concordance.', 'timeFrame': 'Day 1', 'description': 'This measure will count the number of subjects in outcome measures 3, 4, 6 and 9 comparing companions living in the Chicago and Houston metropolitan areas.'}, {'measure': 'Waist Circumference for Persons Doing Self-examinations', 'timeFrame': 'Day 1', 'description': 'This measure will record subject waist circumference in cm.'}, {'measure': 'Concordance Between Self-examination and Clinician Examination Stratified by Waist Circumference.', 'timeFrame': 'Day 1', 'description': 'This measure will record the number of concordant digital anal examination results in persons with less than or equal to 102 cm waist size versus greater than 102 cm waist size. A concordant result means that the subject and clinician agree as to the presence or absence of an abnormality.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anus neoplasm', 'Digital anal rectal examination', 'Self anal examination'], 'conditions': ['Anal Cancer']}, 'referencesModule': {'references': [{'pmid': '40018098', 'type': 'DERIVED', 'citation': 'Nyitray AG, Rosser BRS, Hazra A, Nitkowski J, Smith D, Brzezinski B, Ridolfi TJ, Schneider JA, Chiao EY, Sanos S, Mkonyi E, Mgopa L, Ross MW. Factors associated with decreased anal sphincter tone and the accuracy of forced anal examinations to detect individuals having receptive anal intercourse: an observational study. BMJ Public Health. 2024 Jul 12;2(1):e001039. doi: 10.1136/bmjph-2024-001039. eCollection 2024 Jun.'}, {'pmid': '38352524', 'type': 'DERIVED', 'citation': 'Nyitray AG, Rosser BRS, Hazra A, Nitkowski J, Smith D, Brzezinski B, Ridolfi TJ, Schneider JA, Chiao EY, Sanos S, Mkonyi E, Mgopa LR, Ross MW. Factors associated with decreased anal sphincter tone and the accuracy of forced anal examinations to detect individuals having receptive anal intercourse: An observational study. medRxiv [Preprint]. 2024 Feb 1:2024.01.31.24302098. doi: 10.1101/2024.01.31.24302098.'}]}, 'descriptionModule': {'briefSummary': "Anal cancer is a common cancer among men having sex with men (MSM). We will investigate increasing detection of anal canal tumors through self- or partner-palpation of the anal canal among MSM and trans persons. This study in Houston and Chicago will recruit a sample of 100 couples (i.e., 200 partners) and 600 single persons (one-half HIV-positive), aged ≥ 25 years, who will be taught to perform an ASE or ACE. After performing the exam in private, the individual's ASE and partner's ACE will then be compared with a clinician's DARE. The assessment will be done at each of two visits, spaced 6-months apart. One-half of persons will be randomized to a practice condition to assess how practice affects accuracy and retention of exam procedure. Our hypothesis is that both ASE and ACE at visit 1 will have ≥70% sensitivity and ≥90% specificity using the clinician DARE as the gold standard at each of two visits.", 'detailedDescription': "Even though expert opinion recommends annual digital ano-rectal exams (DARE) for detection of anal cancer tumors among men having sex with men (MSM), the procedure is severely underutilized by clinicians and it is not known how to increase utilization. This is problematic in the context of an extremely high incidence of anal cancer among MSM, no proven treatment for anal precancerous lesions, and lack of screening infrastructure for detecting precancerous lesions, even in high-resource countries.\n\nThe long-term goal of this study is to decrease morbidity and mortality from anal cancer by increasing detection of anal canal tumors through self- or partner-palpation of the anal canal. Preliminary data indicate these exams are feasible and highly acceptable among MSM. In a diverse sample of 200 MSM, 93% of men correctly classified their anal self-exam (ASE) or anal companion exam (ACE) as either normal or abnormal, and 94% said the exams were acceptable. Given these findings, our overall objective is to determine the viability of the ASE and ACE by assessing exam accuracy and consistency of results in two clinic sites. Accuracy will be defined as concordance between clinician DARE and participant exam. The central hypothesis is that both ASE and ACE at visit 1 will have ≥70% sensitivity and ≥90% specificity using the clinician DARE as the gold standard at each of two visits. We will test the hypothesis with three specific aims: 1) Estimate ASE and ACE sensitivity and specificity; 2) Determine independent factors associated with ASE and ACE concordance; and 3) Determine the impact of ASE, ACE, and DARE on survival and quality of life, and evaluate the cost-effectiveness of these strategies among HIV+ and HIV- MSM and transgender persons. The aims will be accomplished with a study in Houston and Chicago with a sample of 100 couples (i.e., 200 partners) and 600 single persons (one-half HIV-positive), aged \\>=25 years, who will perform a clinician-taught ASE or ACE. The individual's ASE and partner's ACE will then be compared with the clinician's DARE. The assessment will be done at each of two visits, spaced six-months apart, to assess retention of exam accuracy.\n\nAt the end of visit 1, one-half of participants, i.e., 300 individuals and 50 couples (stratified by city) will be randomly selected and encouraged to practice the ASE/ACE three months before Visit 2. Study staff will make reminder calls (or emails/texts) and follow-up calls for the scheduled practice session. At the follow-up calls, study staff will record the participant's result for the self/companion exam and the level of anxiety and pain, if any, associated with the exam. If the participant reports more than minimal pain and anxiety, they will be asked to return to the clinic for an exam. Regardless of prior results, all persons will be asked to return for Visit 2."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '25 Years', 'genderBased': True, 'genderDescription': 'Cis-gendered men and transgender persons.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Chicago or Houston Metro Residents\n* Persons who had sex with men in the prior five years\n* Cis-gendered men and transgender persons\n* Age: 25 years and over\n* Access to medical care for referral or treatment\n* Spanish or English speakers/readers\n* Individuals or couples\n* HIV+ or HIV-\n* Persons with or without comorbidities and physical disabilities\n\nExclusion Criteria:\n\n* Unresolved health care provider's diagnosis of anal condyloma, hemorrhoids or anal cancer\n* DARE in the prior three months\n* Plans to move in the following six months"}, 'identificationModule': {'nctId': 'NCT04090060', 'briefTitle': 'The Prevent Anal Cancer Palpation Study', 'organization': {'class': 'OTHER', 'fullName': 'Medical College of Wisconsin'}, 'officialTitle': 'Determining the Accuracy of Self and Partner Anal Exams for Detecting Anal Abnormalities.', 'orgStudyIdInfo': {'id': 'PRO00033000'}, 'secondaryIdInfos': [{'id': 'R01CA232892-01', 'link': 'https://reporter.nih.gov/quickSearch/R01CA232892-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Practice Self-/Companion Exams', 'description': '300 individuals and 50 couples will be randomized to practice arm.', 'interventionNames': ['Behavioral: Practice Self-/Companion Exams']}, {'type': 'OTHER', 'label': 'Control Arm', 'description': '300 individuals and 50 couples will neither be encouraged nor discouraged to practice self-/companion exam.', 'interventionNames': ['Behavioral: Control Arm']}], 'interventions': [{'name': 'Practice Self-/Companion Exams', 'type': 'BEHAVIORAL', 'description': '300 men and 50 couples will be randomized and encouraged to practice anal exams at home before Visit 2. Practice results will be elicited by staff. They will return for Visit 2 (six months after Visit 1). At Visit 2, they will complete a pre- and post-visit computer assisted self-interview. They will receive written instructions. After completing an anal self-exam or anal companion exam at home, they will record the results. At the clinic, they will have a Digital Anal Rectal Exam (DARE) by a clinician who will give the subject his results.', 'armGroupLabels': ['Practice Self-/Companion Exams']}, {'name': 'Control Arm', 'type': 'BEHAVIORAL', 'description': '300 individuals and 50 couples will be randomized to this arm. Following Visit 1, they will neither be encouraged nor discouraged from practicing self- or companion exam. They will return for Visit 2 (six months after Visit 1). They will receive written anal exam instructions. They will then complete the self- or companion exam at home, and record the results. At the clinic, they will receive a clinician DARE. Clinicians will give DARE results. Persons will take a post-exam computer-assisted self-interview. Persons in this arm (control) will be asked if they have performed exams between visits.', 'armGroupLabels': ['Control Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'M.D. Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77098', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Gordon Crofoot MD', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Alan Nyitray, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical College of Wisconsin'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical College of Wisconsin', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Chicago', 'class': 'OTHER'}, {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, {'name': 'Gordon Crofoot MD PA', 'class': 'UNKNOWN'}, {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Alan Nyitray, PhD', 'investigatorAffiliation': 'Medical College of Wisconsin'}}}}