Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2025-12-26 @ 6:33 AM
Study NCT ID:
NCT05694559
Status:
RECRUITING
Last Update Posted:
2025-08-17
First Post:
2023-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Connecting Black Families in Houston, Texas to Hereditary Cancer Genetic Counseling, Genetic Testing, and Cascade Testing by Using a Simple Genetic Risk Screening Tool and Telegenetics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005820', 'term': 'Genetic Testing'}, {'id': 'D003376', 'term': 'Counseling'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'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'}, {'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D003153', 'term': 'Community Health Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-02-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-15', 'studyFirstSubmitDate': '2023-01-12', 'studyFirstSubmitQcDate': '2023-01-20', 'lastUpdatePostDateStruct': {'date': '2025-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'genetic risk screening tool (GRST) questionnaire', 'timeFrame': 'through study completion; an average of 1 year.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer', 'Colorectal Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'MD Anderson Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'To identify Black individuals who are eligible for genetic testing through trusted community organizations, and to connect Black individuals and their families to genetic testing and counseling so that they can know their cancer risk and how to decrease it.', 'detailedDescription': 'Primary Objectives:\n\n* To identify 300 Black families, at least one individual per family, eligible for genetic testing using our validated simple genetic risk screening tool (GRST) 1, via collaboration with trusted community organizations. For individuals eligible for genetic testing, we will counsel them about genetic testing, including reviewing GRST results, explaining why they are eligible for genetic testing as part of standard-of-care, explaining what this entails, offering on-site or remote genetic testing, and explaining that they will be connected to a genetic counselor if they have a pathogenic mutation (PV) of a variant of unknown significance (VUS), including resources for family cascade genetic testing.\n* To provide genetic testing to 150 Black individuals and families and provide genetic counseling and risk reduction resources to individuals with a PV or VUS, including cascade genetic testing for their family members.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Any participant over 18 years old who self-identifies as Black or African-American and signs an informed consent form, also referred to as the 'Permission to Contact' form, to be part of our study.\n\nExclusion Criteria:\n\nNone"}, 'identificationModule': {'nctId': 'NCT05694559', 'briefTitle': 'Connecting Black Families in Houston, Texas to Hereditary Cancer Genetic Counseling, Genetic Testing, and Cascade Testing by Using a Simple Genetic Risk Screening Tool and Telegenetics', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Connecting Black Families in Houston, Texas to Hereditary Cancer Genetic Counseling, Genetic Testing, and Cascade Testing by Using a Simple Genetic Risk Screening Tool and Telegenetics', 'orgStudyIdInfo': {'id': '2022-0328'}, 'secondaryIdInfos': [{'id': 'NCI-2023-00252', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Genetic Testing and Counseling', 'description': 'Participants will be given a saliva collection kit to collect a saliva sample for hereditary cancer and genetic testing.', 'interventionNames': ['Behavioral: Genetic Testing and Counseling']}, {'type': 'EXPERIMENTAL', 'label': 'Screening Form', 'description': 'Participants will complete a screening form to assess your risk of hereditary breast and colorectal cancers. You will be asked to provide your:\n\n* Name and contact information (including your address, phone number, and email)\n* Demographic information (including your age, race, and ethnicity)\n* Health insurance status\n* Annual household income\n* Personal and family history of cancer, including diagnosis and age at diagnosis', 'interventionNames': ['Behavioral: Screening Form']}], 'interventions': [{'name': 'Genetic Testing and Counseling', 'type': 'BEHAVIORAL', 'description': 'Participants will complete testing', 'armGroupLabels': ['Genetic Testing and Counseling']}, {'name': 'Screening Form', 'type': 'BEHAVIORAL', 'description': 'Participants will complete forms with demographics and history', 'armGroupLabels': ['Screening Form']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Banu Arun, MD', 'role': 'CONTACT', 'email': 'barun@mdanderson.org', 'phone': '713-792-2817'}], 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Banu Arun, MD', 'role': 'CONTACT', 'email': 'barun@mdanderson.org', 'phone': '713-792-2817'}], 'overallOfficials': [{'name': 'Banu Arun, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MD Anderson Cancer Cneter'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}