Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2025-12-30 @ 2:47 PM
Study NCT ID:
NCT04254133
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-08-22
First Post:
2020-01-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Genetic Information to Inform Treatment and Screening for Prostate Cancer, GIFTS Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D005820', 'term': 'Genetic Testing'}, {'id': 'D005817', 'term': 'Genetic Counseling'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D033142', 'term': 'Genetic Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D003954', 'term': 'Diagnostic Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1360}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2028-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-20', 'studyFirstSubmitDate': '2020-01-31', 'studyFirstSubmitQcDate': '2020-02-03', 'lastUpdatePostDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identification of a population-based cohort of men with prostate cancer (PC) and germline deoxyribonucleic acid (DNA) repair gene (gDRG) mutations', 'timeFrame': 'From the start of study through death (up to 20 years)', 'description': 'Identification to be determined through the Washington State Cancer Registry and by genetic testing on saliva samples for inherited mutations in cancer risk genes such as BRCA2, BRCA1, ATM, and others in prostate cancer.'}, {'measure': 'Clinical, pathologic, and molecular predictors of gDRG mutation carriers for men with PC', 'timeFrame': 'From the start of study through death (up to 20 years)', 'description': 'Predictors to be identified by analyzing information provided by participants on their health history and potentially further testing or chart review on participants who consent to future contact.'}, {'measure': 'Utility and feasibility of cascade genetic testing through use of family history of men with PC identified to have gDRG mutations', 'timeFrame': 'From the start of study through death (up to 20 years)', 'description': "To be determined by collection of information about participants' family history and subsequent analysis of cascade genetic testing outcomes."}, {'measure': 'Identification of a cohort of men with gDRG mutations without PC', 'timeFrame': 'From the start of study through death (up to 20 years)', 'description': 'Identification to be determined through family history of men with PC identified through the Washington State Cancer Registry and by genetic testing on saliva samples for inherited mutations in cancer risk genes such as BRCA2, BRCA1, ATM, and others in prostate cancer.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostate Carcinoma']}, 'descriptionModule': {'briefSummary': 'This trial studies the role of inherited (present at birth) mutations in cancer risk genes such as BRCA2, BRCA1, ATM, CHEK2, and others in relation to prostate cancer. This study may help researchers understand the frequency and importance of inherited mutations in cancer risk genes in patients with prostate cancer and potentially help identify better ways to treat cancer in patients who have a mutation in one of these genes.', 'detailedDescription': 'OUTLINE:\n\nParticipants complete questionnaire over 20 minutes at baseline, then undergo collection of saliva sample for genetic testing. Participants identified to have an inherited mutation in a deoxyribonucleic acid (DNA) repair gene undergo genetic counseling. Participants whose genetic testing does not indicate an inherited mutation in a DNA repair gene receive a letter thanking them for their participation and emphasizing the importance of ongoing communication with their physician and family members about cancer risk.\n\nParticipants will be sent newsletters every year to encourage study engagement and update health questionnaires every two years.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '35 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients living in Washington State with a new diagnosis of prostate cancer and first degree relatives of patients with prostate cancer', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: Case Ascertainment\n\n* Signed informed consent form providing agreement for germline genetic testing, use and release of health and research information\n* Male aged 35 to 89 years\n* Diagnosis of prostate cancer\n* Resident of Washington state\n* Willing to complete a questionnaire (online or on paper) to provide basic demographic information, family cancer history, and health history\n* Willing and able to provide a saliva sample\n* United States (U.S.) mailing address\n\nInclusion Criteria: Family Recruitment\n\n* Signed informed consent form providing agreement for germline genetic testing, use and release of health and research information\n* Males aged 35 to 89 years\n* Willingness to complete a questionnaire (online or on paper) to provide basic demographic information, family cancer history, and health history\n* Willingness and ability to provide a saliva sample\n* U.S. mailing address\n\nExclusion Criteria: Case Ascertainment\n\n* Unable to provide informed consent, e.g. decisional impairment\n* Prior bone marrow transplant\n* Currently under treatment for a hematologic malignancy\n* Study team members\n\nExclusion Criteria: Family Recruitment\n\n* Unable to provide informed consent, e.g. decisional impairment\n* Prior bone marrow transplant\n* Currently under treatment for a hematologic malignancy\n* Study team members'}, 'identificationModule': {'nctId': 'NCT04254133', 'acronym': 'GIFTS', 'briefTitle': 'Genetic Information to Inform Treatment and Screening for Prostate Cancer, GIFTS Study', 'organization': {'class': 'OTHER', 'fullName': 'Fred Hutchinson Cancer Center'}, 'officialTitle': 'Genetic Information to Inform Treatment and Screening (GIFTS) Study for Prostate Cancer', 'orgStudyIdInfo': {'id': 'RG1004177'}, 'secondaryIdInfos': [{'id': 'P50CA097186', 'link': 'https://reporter.nih.gov/quickSearch/P50CA097186', 'type': 'NIH'}, {'id': 'NCI-2020-00933', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '8754', 'type': 'OTHER', 'domain': 'Fred Hutch/University of Washington Cancer Consortium'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Case Ascertainment', 'description': 'Men with prostate cancer', 'interventionNames': ['Behavioral: Questionnaire', 'Procedure: Biospecimen Collection', 'Diagnostic Test: Genetic Testing', 'Other: Genetic Counseling', 'Other: Laboratory Biomarker Analysis']}, {'label': 'Family Recruitment', 'description': 'Male relatives of men with prostate cancer', 'interventionNames': ['Behavioral: Questionnaire', 'Procedure: Biospecimen Collection', 'Diagnostic Test: Genetic Testing', 'Other: Genetic Counseling', 'Other: Laboratory Biomarker Analysis']}], 'interventions': [{'name': 'Questionnaire', 'type': 'BEHAVIORAL', 'otherNames': ['Questionnaires'], 'description': 'Complete questionnaire', 'armGroupLabels': ['Case Ascertainment', 'Family Recruitment']}, {'name': 'Biospecimen Collection', 'type': 'PROCEDURE', 'otherNames': ['Biological Sample Collection', 'Biospecimen Collected', 'Specimen Collection'], 'description': 'Provide saliva samples', 'armGroupLabels': ['Case Ascertainment', 'Family Recruitment']}, {'name': 'Genetic Testing', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Genetic Analysis', 'Genetic Examination', 'Genetic Test'], 'description': 'Undergo genetic testing', 'armGroupLabels': ['Case Ascertainment', 'Family Recruitment']}, {'name': 'Genetic Counseling', 'type': 'OTHER', 'description': 'Undergo counseling', 'armGroupLabels': ['Case Ascertainment', 'Family Recruitment']}, {'name': 'Laboratory Biomarker Analysis', 'type': 'OTHER', 'description': 'Correlative Studies', 'armGroupLabels': ['Case Ascertainment', 'Family Recruitment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Fred Hutch/University of Washington Cancer Consortium', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Burcu Darst', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fred Hutch/University of Washington Cancer Consortium'}, {'name': 'Heather H Cheng', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fred Hutch/University of Washington Cancer Consortium'}, {'name': 'Daniel W Lin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fred Hutch/University of Washington Cancer Consortium'}, {'name': 'Colin C Pritchard', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fred Hutch/University of Washington Cancer Consortium'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fred Hutchinson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}