Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2026-01-10 @ 12:56 PM
Study NCT ID:
NCT02478892
Status:
RECRUITING
Last Update Posted:
2025-01-13
First Post:
2015-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preliminary Evaluation of Screening for Pancreatic Cancer in Patients with Inherited Genetic Risk
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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Up to 40mL of blood may be collected for analysis at each screening examination.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2030-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-10', 'studyFirstSubmitDate': '2015-06-19', 'studyFirstSubmitQcDate': '2015-06-22', 'lastUpdatePostDateStruct': {'date': '2025-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'identifying pancreatic neoplastic lesions lesions in patients with BRCA1/2 mutations and other less common, but related mutations (ATM, PALB2) as well as mutations identified in the future.', 'timeFrame': '10 years', 'description': 'The primary objective of the study is the observational screening of patients with BRCA1/2, ATM, or, PALB2 mutations for pancreatic neoplastic lesions, to assess for both the feasibility of this approach in this high risk population as well as to better establish the incidence of these lesions in this cohort.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['high risk', 'specifically those with BRCA1/2 mutations'], 'conditions': ['Pancreatic Cancer']}, 'referencesModule': {'references': [{'pmid': '34341011', 'type': 'BACKGROUND', 'citation': 'Katona BW, Long JM, Ahmad NA, Attalla S, Bradbury AR, Carpenter EL, Clark DF, Constantino G, Das KK, Domchek SM, Dudzik C, Ebrahimzadeh J, Ginsberg GG, Heiman J, Kochman ML, Maxwell KN, McKenna DB, Powers J, Shah PD, Wangensteen KJ, Rustgi AK. EUS-based Pancreatic Cancer Surveillance in BRCA1/BRCA2/PALB2/ATM Carriers Without a Family History of Pancreatic Cancer. Cancer Prev Res (Phila). 2021 Nov;14(11):1033-1040. doi: 10.1158/1940-6207.CAPR-21-0161. Epub 2021 Aug 2.'}]}, 'descriptionModule': {'briefSummary': 'The study is a prospective, observational study evaluating the utility of endoscopic ultrasound or MRI for the identification of preneoplastic and neoplastic pancreatic lesions in patients at high risk for pancreatic cancer, specifically those with BRCA1/2, ATM, or PALB2 mutations.', 'detailedDescription': 'Endoscopic Ultrasound (EUS) has emerged as a critical component in the imaging, staging, and diagnosis of pancreatic cancer. Not only can EUS delineate a mass utilizing sonography through the wall of the stomach or duodenum, but it also can obtain diagnostic fine needle aspiration of suspicious lesions. Especially in patients with incomplete visualization of a mass on cross-sectional imaging, EUS can provide valuable anatomic information prior to surgical exploration. While several studies have demonstrated that EUS has high sensitivity and specificity in diagnosing pancreatic masses, head-to-head comparisons with established modalities like CT have been often methodologically flawed. In a meta-analysis, it was found that of 4 studies that assessed resectability, 2 showed no difference and 1 favored each modality. As such, estimates of accuracy for assessing preoperative resectability have also ranged in several studies from 63-93%. As such it has been recognized as an accepted modality for the evaluation of potential pancreatic malignancy.\n\nWhile pancreatic ductal adenocarincoma (PDAC) screening in the general population is not feasible given the low incidence of PDAC, screening in high risk cohorts may allow for early detection of resectable, and potentially curable tumors. Clinical outcome of patients with smaller, non-metastasized tumors have a significantly improved 5-year survival. Generally the current recommendation is that patients who are first degree relatives of patients with PDAC from a familial PDAC kindred with at least 2 directly related relatives, patients with Peutz-Jeghers syndrome, those with a CDKN2A pathogenic germline variant, and those with BRCA1/BRCA2/ATM/PALB2/Lynch pathogenic germline variants with a first or second degree relative with pancreatic cancer would qualify for pancreatic cancer screening. However, there is continued debate about whether family history should be used to determine who is eligible for pancreatic cancer screening. In this study we will be following individuals at the University of Pennsylvania who have a BRCA1, BRCA2, ATM, or PALB2 pathogenic germline variant and who are getting pancreatic cancer screening, regardless of whether or not they have a family history of PDAC. Ultimately, in high-risk individuals, such as BRCA1/2, ATM, and PALB2 carriers, the successful identification of early neoplastic/preneoplastic lesions of the pancreas would allow for timely intervention and likely improved survival in this cohort.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients at high risk for pancreatic cancer, specifically those with pathogenic germline variant in BRCA1, BRCA2, ATM, or PALB2 who will be undergoing pancreatic cancer screening as part of their routine clinical care.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Age \\>= 18\n* Documented germline pathogenic or likely pathogenic BRCA1, BRCA2, ATM, or PALB2 mutation\n* If no history of PDAC in a first or second degree relative, age \\>= 50\n* If there is a history of PDAC in a first or second degree relative, minimum age of eligibility is 10 years younger than the age of onset of the youngest relative with pancreatic cancer\n\nExclusion Criteria\n\n• Pregnancy'}, 'identificationModule': {'nctId': 'NCT02478892', 'briefTitle': 'Preliminary Evaluation of Screening for Pancreatic Cancer in Patients with Inherited Genetic Risk', 'organization': {'class': 'OTHER', 'fullName': 'Abramson Cancer Center at Penn Medicine'}, 'officialTitle': 'Preliminary Evaluation of Screening for Pancreatic Cancer in Patients with Inherited Genetic Risk', 'orgStudyIdInfo': {'id': 'UPCC 26214'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Collection of data from endoscopic ultrasound or MRI/MRCP of the abdomen', 'type': 'OTHER', 'description': "Participants in this study should be undergoing pancreatic cancer screening with endoscopic ultrasound or MRI as part of their standard care. These should typically be done at least every 12 months, and the imaging tests will be ordered as routine clinical tests and will be billed to the participant's insurance. This study does not cover the costs of these screening tests, however the study will track the results of these screening tests."}, {'name': 'Blood sample collection for research', 'type': 'OTHER', 'description': 'Up to 40mL of blood may be collected for analysis at each screening examination.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '19004', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Bryson Katona, MD', 'role': 'CONTACT', 'email': 'Bryson.Katona@pennmedicine.upenn.edu', 'phone': '855-216-0098'}, {'name': 'Bryson Katona, MD', 'role': 'CONTACT'}], 'facility': 'Abramson Cancer Center of the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'centralContacts': [{'name': 'Bryson Katona, MD', 'role': 'CONTACT', 'email': 'Bryson.Katona@pennmedicine.upenn.edu'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abramson Cancer Center at Penn Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}