Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2025-12-29 @ 4:00 AM
Study NCT ID:
NCT00830557
Status:
RECRUITING
Last Update Posted:
2025-01-28
First Post:
2009-01-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Collecting Medical Information and Tissue Samples From Patients With Pancreatic Cancer or Other Pancreatic Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007516', 'term': 'Adenoma, Islet Cell'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D010195', 'term': 'Pancreatitis'}, {'id': 'D050500', 'term': 'Pancreatitis, Chronic'}, {'id': 'C537262', 'term': 'Hereditary pancreatitis'}, {'id': 'D013005', 'term': 'Somatostatinoma'}, {'id': 'D018273', 'term': 'Carcinoma, Islet Cell'}], 'ancestors': [{'id': 'D000236', 'term': 'Adenoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D018278', 'term': 'Carcinoma, Neuroendocrine'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Two 10mL plasma tubes, two 10mL serum tubes and one 10mL heparin tube collected. DNA extracted from lymphocytes. Possible saliva collection for DNA extraction. Waste tissue from prior surgery may be collected. Stool samples may be collected.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12000}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2000-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-24', 'studyFirstSubmitDate': '2009-01-27', 'studyFirstSubmitQcDate': '2009-01-27', 'lastUpdatePostDateStruct': {'date': '2025-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-01-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Collection of clinical data, health and family histories by survey', 'timeFrame': 'baseline enrollment, 6 months, 12 months'}, {'measure': 'Collection of blood and/or tissue, fecal and oral specimens', 'timeFrame': 'baseline'}, {'measure': 'Collection of information regarding food preparation and intake by survey', 'timeFrame': 'baseline'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['recurrent pancreatic cancer', 'stage I pancreatic cancer', 'stage II pancreatic cancer', 'stage III pancreatic cancer', 'stage IV pancreatic cancer', 'recurrent islet cell carcinoma', 'pancreatic alpha cell carcinoma', 'pancreatic beta islet cell carcinoma', 'pancreatic delta cell carcinoma', 'pancreatic G-cell carcinoma'], 'conditions': ['Islet Cell Tumor', 'Pancreatic Cancer', 'Pancreatic Disease', 'Acute Pancreatitis', 'Chronic Pancreatitis', 'Hereditary Pancreatitis', 'Pancreatic Neuroendocrine Carcinoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Gathering medical information and collecting and storing samples of blood and tissue to test in the laboratory may help doctors develop better ways to screen people at risk for pancreatic cancer or other pancreatic disorders in the future.\n\nPURPOSE: This clinical trial is collecting medical information and tissue samples from patients with pancreatic cancer or other pancreatic disorders.', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. To maintain a resource (bank) of biospecimens and data collected from individuals being seen clinically for pancreas conditions to facilitate the discovery and development of (but not limited to) biomarkers of risk (including genomic and proteomic) and early detection as well as novel targeted therapies for pancreatic diseases with a focus on pancreatic cancer.\n\nOUTLINE: This is an observational study.\n\nPatients undergo blood, saliva, and previously obtained leftover tissue sample collection on study. Patients also complete questionnaires and have their medical records reviewed on study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with known or suspected pancreas disease including pancreas adenocarcinoma, islet cell cancer, pancreatic cysts, pancreatitis (hereditary, acute, or chronic) or the next of kin of deceased participants.', 'healthyVolunteers': False, 'eligibilityCriteria': '* Known or suspected pancreas disease including:\n\n * pancreas adenocarcinoma\n * islet cell cancer\n * pancreatic cysts\n * pancreatitis (hereditary, acute, or chronic)\n* Next of kin of deceased participant who did not complete participation before passing away\n\nExclusion Criteria:\n\n* Under the age of 18\n* Unable to provide informed consent\n* Prison inmates'}, 'identificationModule': {'nctId': 'NCT00830557', 'briefTitle': 'Collecting Medical Information and Tissue Samples From Patients With Pancreatic Cancer or Other Pancreatic Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Biospecimen Resource for Pancreas Research, a Data & Tissue Bank (Also Known as a Bio-repository, Bio-bank, Data & Tissue Database, Data & Tissue Registry, Etc.) to Help Advance Research in Pancreas Disease', 'orgStudyIdInfo': {'id': '354-06'}, 'secondaryIdInfos': [{'id': 'P50CA102701-08', 'link': 'https://reporter.nih.gov/quickSearch/P50CA102701-08', 'type': 'NIH'}, {'id': 'CDR0000613100', 'type': 'OTHER', 'domain': 'NCI'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observational', 'description': 'Patients undergo blood, saliva, and previously obtained leftover tissue sample collection on study. Patients also complete questionnaires and have their medical records reviewed on study.', 'interventionNames': ['Other: medical chart review', 'Other: survey administration', 'Other: biospecimen collection']}], 'interventions': [{'name': 'medical chart review', 'type': 'OTHER', 'description': 'baseline, 12 month and 36 months', 'armGroupLabels': ['Observational']}, {'name': 'survey administration', 'type': 'OTHER', 'description': 'baseline, 6 month, 12 month', 'armGroupLabels': ['Observational']}, {'name': 'biospecimen collection', 'type': 'OTHER', 'description': 'baseline', 'armGroupLabels': ['Observational']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85054', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Pancreas Team', 'role': 'CONTACT', 'email': 'pancreas@mayo.edu', 'phone': '480-301-8000'}, {'name': 'Zhi Fong, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayo Clinic Hospital in Arizona', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '32224-9980', 'city': 'Jacksonville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Pancreas Team', 'role': 'CONTACT', 'email': 'pancreas@mayo.edu', 'phone': '904-953-6970'}, {'name': 'Michael Wallace, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayo Clinic in Florida', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Clinical Trials Referral Office', 'role': 'CONTACT', 'email': 'pancreas@mayo.edu', 'phone': '507-538-7623'}, {'name': 'Shounak Majumder, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'centralContacts': [{'name': 'Adriana Delgado, MA', 'role': 'CONTACT', 'email': 'pancreas@mayo.edu', 'phone': '1-800-914-7962'}, {'name': 'Heather M Streich, CCRP', 'role': 'CONTACT', 'email': 'pancreas@mayo.edu', 'phone': '1-800-914-7962'}], 'overallOfficials': [{'name': 'Shounak Majumder, MD', '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'}}}}