Ignite Creation Date:
2025-12-24 @ 4:13 PM
Ignite Modification Date:
2026-01-03 @ 8:14 PM
Study NCT ID:
NCT00505466
Status:
COMPLETED
Last Update Posted:
2022-03-04
First Post:
2007-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transition From Research to Disclosure in Human Genetics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005817', 'term': 'Genetic Counseling'}], 'ancestors': [{'id': 'D033142', 'term': 'Genetic Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Optional small sample of blood (about 6 tablespoons) for genetic testing for p53 following pre-test genetic counseling.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 577}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-05-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-02-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-03', 'studyFirstSubmitDate': '2007-07-19', 'studyFirstSubmitQcDate': '2007-07-20', 'lastUpdatePostDateStruct': {'date': '2022-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-07-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-02-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Received Pre-test Genetic Counseling', 'timeFrame': '10 Years'}], 'secondaryOutcomes': [{'measure': 'Number of participants completing genetic testing for p53', 'timeFrame': 'Baseline to time of follow-up (2 weeks, 6, and 12 months)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Human Genetics', 'Genetic Counseling', 'Genetic Testing', 'p53 Mutation', 'Genetics'], 'conditions': ['Education']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'University of Texas MD Anderson Cancer Center Website'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to design a means of providing research families, from diverse geographical locations, the chance to receive genetic testing after having been educated by video, and meetings or telephone conversations with a genetic counselor/study professional.\n\nThis is an investigational study. About 800 people will be offered genetic testing. This study is being performed only at MD Anderson.', 'detailedDescription': 'Participants will receive pre-test genetic counseling in one of three ways: (1) in person at MD Anderson; (2) by telephone with an MD Anderson Genetic Counselor/study professional; (3) with a local Genetic Counselor in conference with the MD Anderson Genetic Counselor/study professional. After receiving pre-test genetic counseling, participants will be given the opportunity to schedule a submission of a small sample of blood (about 6 tablespoons) for genetic testing for p53. You may have this blood test repeated if there are any problems in the lab. The study doctor will discuss this with you.\n\nParticipants who submit a sample may choose to see a genetic counselor/study professional in person or schedule a phone conversation to receive the results of the genetic test. Genetic counseling may take place at MD Anderson at no cost. Participants may wish to have counseling close to their home, though they then are responsible for the cost of the counseling. If, after talking to the counselor/study professional, the participant wants to know the results of the test, he or she will be told. A participant will be given more counseling and advice on what other care might be needed and what other actions they should take.\n\nThe test results will be kept private. Names will not be used in computer records.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient diagnosed with cancer or a participant with a family member who has had cancer.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n2.0 Genetic testing\n\nMembers of families who have participated in the p53 project through Dr. Strong's lab are eligible, via protocol P90-001. There are at least 145 kindreds including at least 800 participants living who may be at risk of carrying a p53 germline mutation. The participants must provide an informed consent and be 18 years or older. We will include English and non-English speaking participants. For non-English speaking participants to be recruited, the consent documents has been translated into the language of the target population in accordance with the IRB procedures.\n\n2.1 Parents Attitudes toward testing children at risk for TP53 mutations\n\nFor the survey portion of this study, we will invite individuals who 1) are already enrolled in the P90-001 study), 2) have been known to carry a germline p53 mutation, and 3) have children who are less than 27 years old. Patients who agree to enroll in the survey portion of the study will be presented with a consent statement and a printed copy of the survey along with a postage-paid envelope which they can return (either by mail or in person) at their convenience.\n\n2.2 Psychosocial impact of participating in LFS screening\n\n1. Adults who have undergone genetic testing and have a confirmed p53 mutation\n2. Adults participating in LFS screening program\n\nExclusion Criteria:\n\nN/A"}, 'identificationModule': {'nctId': 'NCT00505466', 'briefTitle': 'Transition From Research to Disclosure in Human Genetics', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Transition From Research to Disclosure in Human Genetics', 'orgStudyIdInfo': {'id': 'BS99-038'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pre-Test Genetic Counseling + Genetic Sample', 'interventionNames': ['Behavioral: Genetic Counseling']}], 'interventions': [{'name': 'Genetic Counseling', 'type': 'BEHAVIORAL', 'description': 'Genetic counseling conducted in person, by telephone with an M. D. Anderson Genetic Counselor, or with a local Genetic Counselor in conference with the M. D. Anderson Genetic Counselor.', 'armGroupLabels': ['Pre-Test Genetic Counseling + Genetic Sample']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Louise C. Strong, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}