Ignite Creation Date:
2025-12-25 @ 3:02 AM
Ignite Modification Date:
2026-01-06 @ 4:03 PM
Study NCT ID:
NCT03851133
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-05
First Post:
2019-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Florida Pancreas Collaborative Next Generation Biobank
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003625', 'term': 'Data Collection'}], 'ancestors': [{'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole Blood, Plasma, Serum, Tumor tissue from biopsy or surgery, Muscle and fat tissue from surgery'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-03-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-06-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-04', 'studyFirstSubmitDate': '2019-02-12', 'studyFirstSubmitQcDate': '2019-02-20', 'lastUpdatePostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evidence of Precachexia', 'timeFrame': 'Up to 12 months', 'description': 'Cases will be evaluated for precachexia using the following guidelines: Anorexia with \\<5% weight loss over past 6 months along with metabolic changes that together indicate precachexia.'}, {'measure': 'Evidence of Cachexia', 'timeFrame': 'Up to 12 months', 'description': 'Cases will be evaluated for cachexia using the following guidelines: Anorexia with \\>5% weight loss over past 6 months, along with metabolic changes that together indicate cachexia.'}, {'measure': 'Evidence of Refractory Cachexia', 'timeFrame': 'Up to 12 months', 'description': 'Cases will be evaluated for refractory cachexia using the following guidelines: Anorexia \\>5% weight loss over 6 months along with specific metabolic changes that together indicate refractory cachexia.'}, {'measure': 'Presence of Myopenia', 'timeFrame': 'Up to 12 months', 'description': 'Measures of skeletal muscle index (SMI) and psoas muscle index (PMI) for will be used for myopenia assessment.'}, {'measure': 'Presence of Visceral Adiposity', 'timeFrame': 'Up to 12 months', 'description': 'Using CT scans at the axial L2-L3 level, the following radiologic measures of abdominal adiposity will be obtained: visceral fat area (VFA), subcutaneous fat area (SFA), total abdominal fat (TAF) area, and the VFA to SFA ratio (V/S). The VFA to SFA ratio (V/S) will be calculated with V/S \\> 0.4 defined as viscerally obese.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'Up to 24 months', 'description': 'Overall Survival will be defined as time from surgery to death from any cause'}, {'measure': 'Progression Free Survival', 'timeFrame': 'Up to 24 months', 'description': 'Progression Free Survival will be defined as time from surgery to pancreatic cancer recurrence or death.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pancreas', 'biobank', 'quantitative imaging', 'biomarkers', 'health disparities'], 'conditions': ['Pancreatic Cancer', 'Cancer Cachexia']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to partner with individuals known or suspected to have pancreatic cancer to build a biobank dedicated to minimizing disparities and personalizing care for individuals affected by pancreatic cancer. A biobank is a resource that involves collection, processing and storage of blood, other bodily fluids, and tissue.', 'detailedDescription': "Doctors, researchers, and patient advocates from numerous institutions throughout the state of Florida have formed a partnership known as the Florida Pancreas Collaborative. The goals of the Florida Pancreas Collaborative team are to find better ways to diagnose and treat pancreatic cancer and improve quality of life. Recent research suggests that pancreatic cancer affects people of various racial and ethnic groups differently, with some groups having more aggressive disease and a poorer prognosis than other groups.\n\nIn this research study, the investigators want to partner with individuals known or suspected to have pancreatic cancer to build a 'biobank' dedicated to minimizing disparities and personalizing care for individuals affected by pancreatic cancer. A biobank is a valuable resource that involves collection, processing, and storage of blood, other bodily fluids, and tissue (obtained during biopsy or surgery) to improve the investigator's understanding of health and disease. When combined with information and medical images obtained through routine care, the investigators will be able to investigate biological processes that may underlie differences and poor outcomes and target them with more effective therapeutic strategies tailored to the individual."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients presenting at any of the participating sites with a diagnosis or suspicion or pancreatic cancer', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older.\n* Patient presents for evaluation at a participating site with a strong clinical suspicion or diagnosis of a pancreatic cancer primary based on symptoms, imaging, biopsy, and/or blood-work and has not had treatment.\n* Patient self-reports as Non-Hispanic White, African American, or Hispanic.\n* Able to understand and voluntarily sign the informed consent.\n* Willing to complete study questionnaire(s) and donate medical images and biological specimens (including tissue and blood) obtained at the time of standard of care procedures (biopsy, surgery, and/or venipuncture) after signing the informed consent document.\n\nExclusion Criteria:\n\n* No suspicion or diagnosis of pancreatic cancer.\n* Has a diagnosis of pancreatic cancer but and has already undergone treatment (which may include surgery, chemotherapy, and/or radiation).\n* Self-reported race/ethnicity other than Non-Hispanic White, African American, or Hispanic.\n* Unable to provide informed consent.\n* Unwilling to complete study questionnaires(s) and/or donate biological specimens'}, 'identificationModule': {'nctId': 'NCT03851133', 'briefTitle': 'Florida Pancreas Collaborative Next Generation Biobank', 'organization': {'class': 'OTHER', 'fullName': 'H. Lee Moffitt Cancer Center and Research Institute'}, 'officialTitle': 'The Florida Pancreas Collaborative Next-Generation Biobank: Reducing Health Disparities and Improving Survival for Pancreatic Cancer', 'orgStudyIdInfo': {'id': 'MCC-19717'}, 'secondaryIdInfos': [{'id': '8JK02', 'type': 'OTHER', 'domain': 'Florida Department of Health'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'All Participants', 'description': 'Blood samples, tumor samples and data will be collected from all participants as applicable.', 'interventionNames': ['Other: Blood Sample Collection', 'Other: Tumor Sample collection', 'Other: Data Collection']}], 'interventions': [{'name': 'Blood Sample Collection', 'type': 'OTHER', 'description': 'Participants will be asked to donate blood at baseline (+/- 30 days of diagnosis date) and at the time of follow-up (approximately 6 months and approximately 12 months after baseline).', 'armGroupLabels': ['All Participants']}, {'name': 'Tumor Sample collection', 'type': 'OTHER', 'description': 'At the time of tissue biopsy and surgical resection (if applicable), pancreatic tumor tissue and tissue from site of metastasis will be collected.', 'armGroupLabels': ['All Participants']}, {'name': 'Data Collection', 'type': 'OTHER', 'description': 'Participants will be asked to complete a 3 page screening tool at the time of their in-person clinic visit, as well as questionnaires at baseline and at 6 and 12 months.', 'armGroupLabels': ['All Participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33905', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Lee Memorial Hospital Regional Cancer Center', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '32610-0109', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida - Gainesville', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '33016', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'Palmetto General Hospital', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '32209', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida - Jacksonville', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33805', 'city': 'Lakeland', 'state': 'Florida', 'country': 'United States', 'facility': 'Lakeland Regional Health', 'geoPoint': {'lat': 28.03947, 'lon': -81.9498}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Sylvester Comprehensive Cancer Center & Jackson Memorial Hospital', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33140', 'city': 'Miami Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Mount Sinai Medical Center', 'geoPoint': {'lat': 25.79065, 'lon': -80.13005}}, {'zip': '32804', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Advent Health - Orlando', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida - Orlando', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '34239', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Sarasota Memorial Hospital', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '33705', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': "St Anthony's Baycare/Bay Surgical Specialists", 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '32308', 'city': 'Tallahassee', 'state': 'Florida', 'country': 'United States', 'facility': 'Tallahassee Memorial Healthcare', 'geoPoint': {'lat': 30.43826, 'lon': -84.28073}}, {'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'University of South Florida/Tampa General Hospital', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'H Lee Moffitt Cancer Center and Research Institute', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}], 'overallOfficials': [{'name': 'Jennifer Permuth, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'H. Lee Moffitt Cancer Center and Research Institute'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Will be available approximately one year after study ends, approximately September 2022. End of availability undetermined at this time.', 'ipdSharing': 'YES', 'description': "Investigators requesting to use Florida Pancreas Collaborative (FPC) data, images, and/or biospecimens will need to submit a written proposal to the FPC biobank utilization committee. Decisions will be based on scientific merit, specimen availability, experience of the requesting investigator, and resources to conduct proposed methods. De-identified samples and/or data will be released if the concept receives approval and after scientific review committee and IRB approval is obtained, conflict of interests are checked, and a material transfer agreement is established. Intellectual property issues will need to be agreed upon. If access is granted, the biobank utilization committee may monitor the Investigator's Research studies to ensure appropriate use of the biospecimens and/or data. The Investigator shall provide a written summary of their research findings and reference this funding source in future manuscripts and presentations.", 'accessCriteria': 'Data and specimens will be shared with researchers interested in this topic area who wish to pursue analyses that may be descriptive, analytic, molecular, or correlative in nature. The access criteria used to share IPD and any additional supporting information will involve a formal process which involves submitting a written proposal to the FPC biobank utilization committee. Decisions will be based on scientific merit, specimen availability, experience of the requesting investigator, and resources to conduct proposed methods. Samples and/or data will be released if the concept receives approval and after scientific review committee and IRB approval is obtained, conflict of interests (COI) are checked, a material transfer agreement is established between institutions, and intellectual property issues are agreed upon. The release of data will be based on the nature of the request and can represent aggregate or individual-level data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'H. Lee Moffitt Cancer Center and Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}