Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2026-03-01 @ 10:10 AM
Study NCT ID:
NCT00835133
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-27
First Post:
2009-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Collecting Blood and Tissue Samples From Family Members of Patients With Pancreatic Diseases, Pancreatic Cancer, and Melanoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C535837', 'term': 'Pancreatic carcinoma, familial'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008545', 'term': 'Melanoma'}], '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': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Two 10mL plasma tubes and two 10mL serum tubes collected. DNA extracted from blood lymphocytes.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'FAMILY_BASED'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1122}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2002-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-26', 'studyFirstSubmitDate': '2009-01-31', 'studyFirstSubmitQcDate': '2009-01-31', 'lastUpdatePostDateStruct': {'date': '2025-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-02-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Collection of familial data and biospecimens in a data and tissue repository for familial pancreas research', 'timeFrame': 'baseline'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['family', 'history', 'pancreas', 'cancer', 'melanoma', 'genetic'], 'conditions': ['Familial Pancreatic Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Collecting and storing samples of blood and tissue from family members of patients with cancer to test in the laboratory may help the study of cancer in the future.\n\nPURPOSE: This clinical trial is collecting blood and tissue samples from family members of patients with pancreatic disease, pancreatic cancer, and melanoma.', 'detailedDescription': 'OBJECTIVES:\n\n* To collect clinical history, family history, and blood and/or tissue samples from family members of patients diagnosed with pancreatic diseases, pancreatic cancer, or melanoma.\n* To learn whether inherited factors increase the risk of pancreatic diseases, pancreatic cancer, or other cancers.\n\nOUTLINE: Study participants undergo collection of blood and/or tissue samples as well as survey data for inclusion in a familial data and tissue registry. Participants complete two baseline surveys regarding their personal, family, health, and environmental exposure histories and regarding their opinions on cancer and cancer screening. Patients also complete a follow-up survey at 1 year and undergo review of their medical records.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Familial pancreatic cancer kindred', 'healthyVolunteers': True, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Meets 1 of the following criteria:\n\n * Has at least 2 blood relatives with pancreatic cancer (both must be related)\n * Has at least 1 blood relative with pancreatic cancer and 1 with melanoma (both must be related)\n\nPATIENT CHARACTERISTICS:\n\n* Mentally competent and able to provide informed consent\n* Able to understand and read English\n\nPRIOR CONCURRENT THERAPY:\n\n* Not specified'}, 'identificationModule': {'nctId': 'NCT00835133', 'briefTitle': 'Collecting Blood and Tissue Samples From Family Members of Patients With Pancreatic Diseases, Pancreatic Cancer, and Melanoma', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Biospecimen Resource for Familial Pancreas Research, a Data and Tissue Registry (Also Known as a Bio-repository, Bio-bank, Data and Tissue Database, Data and Tissue Bank, Etc.) to Help Advance Research in Familial Pancreas Disease', 'orgStudyIdInfo': {'id': '355-06'}, 'secondaryIdInfos': [{'id': 'R01CA097075-08', 'link': 'https://reporter.nih.gov/quickSearch/R01CA097075-08', 'type': 'NIH'}, {'id': 'CDR0000613097', 'type': 'REGISTRY', 'domain': 'NCI'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'biologic sample preservation procedure', 'type': 'OTHER', 'description': 'one blood sample'}, {'name': 'medical chart review', 'type': 'OTHER', 'description': 'confirmation of cancer diagnosis'}, {'name': 'survey administration', 'type': 'OTHER', 'description': 'at baseline enrollment and 12 months post-enrollment'}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic Cancer Center', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Shounak Majumder, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Shounak Majumder', 'investigatorAffiliation': 'Mayo Clinic'}}}}