Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2026-02-25 @ 9:41 PM
Study NCT ID:
NCT00672269
Status:
UNKNOWN
Last Update Posted:
2009-02-04
First Post:
2008-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Investigating MEN1 and SDHD in Familial Carcinoid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002276', 'term': 'Carcinoid Tumor'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood: a small sample of 2 tubes (2 - 4 teaspoons, or 20 ml). One tube will be used to prepare the DNA (your genetic material) for the test. The other would be used for further gene evaluation. The DNA will be stored with Rutgers University Cell and DNA Repository (RUCDR).'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2010-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-02-03', 'studyFirstSubmitDate': '2008-05-02', 'studyFirstSubmitQcDate': '2008-05-05', 'lastUpdatePostDateStruct': {'date': '2009-02-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mutations in MEN1 and SDHD genes', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['carcinoid', 'family members', 'familial', 'tumors', 'cancer'], 'conditions': ['Carcinoid Neuroendocrine Cancer']}, 'descriptionModule': {'briefSummary': 'There is a high incidence among the first degree relatives of the carcinoid patients, indicating the involvement of genetic components in its initiation and pathogenesis.', 'detailedDescription': 'This proposed pilot study will conduct detailed interviews into the medical, environmental, and family histories and to collect blood specimen to obtain DNA. The Blood specimen and DNA will be processed by the Rutgers University Cell and DNA Repository (RUCDR) to rule out Familial Multiple Endocrine Neoplasia (MEN 1), and succinate dehydrogenase complex, subunit D (SDHD), gene inactivation thought to be associated with different types of carcinoid cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals with carcinoid cancer that report to have a first-degree family member also with carcinoid tumor', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Over the age of 18 years\n2. More than one ,member of a family with a history of biopsy confirmed carcinoid tumor\n3. English speaking\n4. Mentally and emotionally capable of answering questions\n5. Willing and available for study participation\n6. At least one other family member with carcinoid tumor\n\nExclusion Criteria:\n\n1. If you are under the age of 18 years,\n2. If you are unable to understand or unable to provide informed consent,\n3. If you have a psychological condition (i.e. depression, anxiety disorder, substance abuse, etc.) which might cause you significant problems in dealing with test results.'}, 'identificationModule': {'nctId': 'NCT00672269', 'briefTitle': 'Study Investigating MEN1 and SDHD in Familial Carcinoid Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Rutgers University'}, 'officialTitle': 'A Pilot Study to Investigate Germ-Line MEN1 and SDHD Gene Mutation in Familial Cases of Carcinoid Cancer', 'orgStudyIdInfo': {'id': '08-451'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Families with carcinoid in multiple family members'}]}, 'contactsLocationsModule': {'locations': [{'zip': '08854-8082', 'city': 'Piscataway', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Changshun Shao, PhD', 'role': 'CONTACT', 'email': 'shao@biology.rutgers.edu', 'phone': '732-445-5406'}, {'name': 'Nancy Gardner, PhD', 'role': 'CONTACT', 'email': 'gardnern@rutgers.edu', 'phone': '973-991-1302'}, {'name': 'Changshun Shao, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Nancy Gardner, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Busch Campus of Rutgers University, Human Genetics Institute', 'geoPoint': {'lat': 40.49927, 'lon': -74.39904}}], 'centralContacts': [{'name': 'Nancy Gardner, PhD', 'role': 'CONTACT', 'email': 'gardnern@rutgers.edu', 'phone': '813-731-0894'}, {'name': 'Changshun Shao, PhD', 'role': 'CONTACT', 'email': 'Shao@Biology.Rutgers.Edu'}], 'overallOfficials': [{'name': 'Nancy Gardner, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rutgers University'}, {'name': 'Changshun Shao, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rutgers University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rutgers University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Nancy Gardner PhD Principal Investigator', 'oldOrganization': 'Rutgers University'}}}}