Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2026-04-14 @ 10:25 PM
Study NCT ID:
NCT02309632
Status:
WITHDRAWN
Last Update Posted:
2019-07-29
First Post:
2014-12-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pancreatic Cancer Screening of High-Risk Individuals in Arkansas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D010580', 'term': 'Peutz-Jeghers Syndrome'}, {'id': 'D001260', 'term': 'Ataxia Telangiectasia'}, {'id': 'D000096142', 'term': 'Melanoma, Cutaneous Malignant'}, {'id': 'D003123', 'term': 'Colorectal Neoplasms, Hereditary Nonpolyposis'}, {'id': 'C537262', 'term': 'Hereditary pancreatitis'}], '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'}, {'id': 'D009386', 'term': 'Neoplastic Syndromes, Hereditary'}, {'id': 'D044483', 'term': 'Intestinal Polyposis'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007911', 'term': 'Lentigo'}, {'id': 'D008548', 'term': 'Melanosis'}, {'id': 'D017495', 'term': 'Hyperpigmentation'}, {'id': 'D010859', 'term': 'Pigmentation Disorders'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D020754', 'term': 'Spinocerebellar Ataxias'}, {'id': 'D002524', 'term': 'Cerebellar Ataxia'}, {'id': 'D002526', 'term': 'Cerebellar Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020752', 'term': 'Neurocutaneous Syndromes'}, {'id': 'D001259', 'term': 'Ataxia'}, {'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D013684', 'term': 'Telangiectasis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000081207', 'term': 'Primary Immunodeficiency Diseases'}, {'id': 'D049914', 'term': 'DNA Repair-Deficiency Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D008545', 'term': 'Melanoma'}, {'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': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D003108', 'term': 'Colonic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Lack of funding', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2015-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-07-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-25', 'studyFirstSubmitDate': '2014-12-03', 'studyFirstSubmitQcDate': '2014-12-03', 'lastUpdatePostDateStruct': {'date': '2019-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-07-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detection rate of PC and precancerous lesion', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pancreatic Neoplasms', "Peutz-Jegher's Syndrome", 'BRCA1 Gene Mutation', 'BRCA2 Gene Mutation', 'Ataxia Telangiectasia', 'Familial Atypical Mole-Malignant Melanoma Syndrome', 'Colorectal Neoplasms, Hereditary Nonpolyposis', 'Hereditary Pancreatitis']}, 'descriptionModule': {'briefSummary': '100 subjects who have a family history of pancreatic cancer (PC), or known genetic syndromes associated with increased risk of pancreatic cancer, will be followed for five years. This data will be used to determine the pancreatic cancer and precancerous lesion detection rate in High Risk Individuals (HRIs). Subjects may agree to annual imaging and annual biomarkers or to biomarkers only.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have a family history of PC as listed below or who have one of the following syndromes: Peutz-Jeghers syndrome - STK11; BRCA 1 and 2; PALB2; ATM; FAMMM / P16; HNPCC (Lynch) / MMR genes; Hereditary pancreatitis - PRSS1\n* Individuals with three or more affected blood relatives (1st, 2nd or 3rd degree)\n* Individuals with two or more affected blood relatives with PC, with at least one affected FDR, should be considered for screening.\n* Patients with a history of Peutz-Jeghers syndrome should be screened, regardless of family history of PC.\n* Patients with a known p16 (FAMMM syndrome) with one affected 1st or 2nd degree relative will be considered for screening.\n* Patients with a known BRCA1 or BRCA2 mutation with one affected 1st or 2nd degree relative should be considered for screening.\n* Patients with a known PALB2 mutation with one affected family member should be considered for screening.\n* Patients with a known Mismatch-repair gene-mutation carriers (Lynch syndrome) with one affected family member should be considered for screening.\n\nExclusion Criteria:\n\n* Not candidates for surgery'}, 'identificationModule': {'nctId': 'NCT02309632', 'briefTitle': 'Pancreatic Cancer Screening of High-Risk Individuals in Arkansas', 'organization': {'class': 'OTHER', 'fullName': 'University of Arkansas'}, 'officialTitle': 'Pancreatic Cancer Screening of High-Risk Individuals in Arkansas', 'orgStudyIdInfo': {'id': '203640'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Pathway 1', 'description': 'Individuals at high risk of pancreatic cancer who will participate in Pancreatic Cancer Screening Pathway 1', 'interventionNames': ['Other: Pancreatic Cancer Screening Pathway 1']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pathway2', 'description': 'Individuals at high risk of pancreatic cancer who will participate in Pancreatic Cancer Screening Pathway 2', 'interventionNames': ['Other: Pancreatic Cancer Screening Pathway 2']}], 'interventions': [{'name': 'Pancreatic Cancer Screening Pathway 1', 'type': 'OTHER', 'description': 'Screening with imaging and biomarker testing', 'armGroupLabels': ['Pathway 1']}, {'name': 'Pancreatic Cancer Screening Pathway 2', 'type': 'OTHER', 'description': 'Screening with biomarker testing only', 'armGroupLabels': ['Pathway2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'University of Arkansas for Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}], 'overallOfficials': [{'name': 'Kent D McKelvey, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Arkansas'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Arkansas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}