Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2026-03-11 @ 4:43 PM
Study NCT ID:
NCT04266093
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-12-24
First Post:
2020-02-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gene Therapy Follow up Protocol for Subjects Previously Enrolled in NCI Center for Immuno-Oncology Studies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002578', 'term': 'Uterine Cervical Dysplasia'}, {'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D009959', 'term': 'Oropharyngeal Neoplasms'}, {'id': 'D065310', 'term': 'Squamous Intraepithelial Lesions of the Cervix'}], 'ancestors': [{'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D010610', 'term': 'Pharyngeal Neoplasms'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D000081483', 'term': 'Squamous Intraepithelial Lesions'}, {'id': 'D065308', 'term': 'Morphological and Microscopic Findings'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2020-05-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11-03', 'completionDateStruct': {'date': '2050-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-23', 'studyFirstSubmitDate': '2020-02-11', 'studyFirstSubmitQcDate': '2020-02-11', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2035-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To provide long term follow up of patients previously enrolled on treatment protocols in the NCI CIO.', 'timeFrame': '15 years', 'description': 'List of long time adverse event frequency after Gene therapy drug'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gene Transfer', 'Recombinant DNA Product', 'Gamma-Retroviral Vectors', 'Laboratory Evaluation', 'Natural History'], 'conditions': ['Cervical Intraepithelial Neoplasia', 'Cervical Neoplasms', 'Oropharyngeal Neoplasms', 'Squamous Intraepithelial Lesions of the Cervix', 'Hematologic Malignacies']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2020-C-0051.html', 'label': 'NIH Clinical Center Detailed Web Page'}]}, 'descriptionModule': {'briefSummary': 'Background:\n\nGene therapy is closely followed by the U.S. Food and Drug Administration (FDA). The FDA requires researchers to conduct long-term follow-up of people who have had the treatment. This study collects data on people who have had gene therapy and sends it to the FDA. The data does not include participants names.\n\nObjective:\n\nTo contact current or past participants of gene therapy protocols at least once a year for up to 15 years to ensure they have not had any harmful side effects.\n\nEligibility:\n\nPeople aged 18 and older who have had gene therapy in a National Cancer Institute study\n\nDesign:\n\nParticipants will give their address and telephone number. They will also give and the address and phone number of 1 or 2 other people who will know where they are.\n\nFor the first year after gene therapy, participants will give blood samples 3 times (at 3, 6, and 12 months). For the next 4 years, they may have a physical exam and laboratory tests with a home physician. They will get a kit to mail in blood samples. Or they can visit the NIH Clinical Center. They will be asked if they have had any signs of neurological, autoimmune, or blood disorders, or any new cancers.\n\nFor years 6 to 15, participants will be contacted yearly via phone or email and asked questions about their health. They may give blood samples.\n\nWhen the participant dies, if researchers think the death was caused by gene therapy, they will ask the participant s family to allow an autopsy.', 'detailedDescription': 'Background:\n\nThe NCI CIO conducts clinical trials utilizing gene transfer. The current FDA requirements for long term follow up may be up to fifteen years for some products. As this time period is frequently longer than studies are expected to be open, a protocol is necessary to ensure the necessary follow up of these subjects\n\nObjectives:\n\nTo facilitate collection of long term follow up information on subjects who have participated in gene transfer studies as required by the U.S. Food and Drug Administration and other regulatory groups\n\nEligibility:\n\nEnrollment on a NCI CIO treatment protocol for gene therapy.\n\nDesign:\n\nPatients will undergo physical exams, laboratory evaluations and/or phone follow up as required by the treatment protocol and/or as clinically indicated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'To facilitate collection of long term follow up information on subjects who have participated in gene transfer studies as required by the U.S. Food and Drug Administration and other regulatory groups', 'healthyVolunteers': False, 'eligibilityCriteria': '* INCLUSION CRITERIA:\n* Subjects who have enrolled on an applicable NCI CIO gene therapy treatment protocol. Age \\>= 18 years. Note: Children are generally excluded from CIO gene therapy studies and inclusion on this follow-up study will be limited to 18 years and older.\n\nEXCLUSION CRITERIA:\n\n-Children'}, 'identificationModule': {'nctId': 'NCT04266093', 'briefTitle': 'Gene Therapy Follow up Protocol for Subjects Previously Enrolled in NCI Center for Immuno-Oncology Studies', 'organization': {'class': 'NIH', 'fullName': 'National Institutes of Health Clinical Center (CC)'}, 'officialTitle': 'Gene Therapy Follow up Protocol for Subjects Previously Enrolled in NCI Center for Immuno-Oncology Studies', 'orgStudyIdInfo': {'id': '200051'}, 'secondaryIdInfos': [{'id': '20-C-0051'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort 1', 'description': 'Subjects who have enrolled on an applicable NCI CIO gene therapy treatment protocol.', 'interventionNames': ['Drug: GeneTherapy']}], 'interventions': [{'name': 'GeneTherapy', 'type': 'DRUG', 'description': 'Observation/ Gene Therapy Long-term Follow-up. Subjects who have enrolled on an applicable NCI CIO gene therapy treatment protocol.', 'armGroupLabels': ['Cohort 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'National Institutes of Health Clinical Center', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}], 'overallOfficials': [{'name': 'Scott M Norberg, D.O.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cancer Institute (NCI)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}