Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2026-02-03 @ 6:54 AM
Study NCT ID:
NCT03060720
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-14
First Post:
2017-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Systematic Hereditary Pancreatic Cancer Risk Assessment and Implications for Personalized Therapy
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 271}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-02-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-12', 'studyFirstSubmitDate': '2017-02-15', 'studyFirstSubmitQcDate': '2017-02-17', 'lastUpdatePostDateStruct': {'date': '2025-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'We will measure clinical factors (e.g. # of PDAC patients with a personal history of x,y,z; # of PDAC patients with a family history of x,y,z; # PDAC patients with a germline mutation in x,y,z) so as to develop a risk assessment tool', 'timeFrame': 'Up to 5 years'}], 'secondaryOutcomes': [{'measure': 'Evaluate Patient Experience With Genetic Testing', 'timeFrame': 'up to 5 years'}, {'measure': 'Summarize patient satisfaction with Genetic counseling', 'timeFrame': 'up to 5 years'}, {'measure': 'Number of patients who disclose genetic testing results to relatives', 'timeFrame': 'up to 5 years'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pancreatic Cancer'], 'conditions': ['Pancreatic Cancer']}, 'descriptionModule': {'briefSummary': 'This research study is looking at people with cancer of the pancreas to find clinical factors that can explain the presence of genetic mutations', 'detailedDescription': "This research is being done to identify which pancreatic cancer patients should undergo genetic evaluation. A patient's personal and family history of cancer is the information typically used to make this decision, but there are currently no accurate, evidence-based guidelines that exist to help doctors use this information to make a decision.\n\nThe investigators hope that by testing all new pancreatic cancer patients, they can determine which clinical factors predict for genetic mutations in order to create a risk assessment tool.\n\nThe investigators want to determine which patients with pancreatic cancer will benefit from genetic testing. To do so, the investigators will offer all patients with pancreatic cancer in the Dana-Farber Gastrointestinal Oncology clinic referral for genetic evaluation. At the Cancer Genetics and Prevention clinic appointment, the provider will review the patient's personal and familial history of cancer and offer genetic testing."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patient seen at Dana Farber Cancer Institute with a diagnosis of pancreatic ductal adenocarcinoma', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of pancreatic ductal adenocarcinoma\n* Signed initial informed consent\n* Participant agrees to genetic counseling\n\nExclusion Criteria:\n\n* Prospective participant unable to sign informed consent based on referring physician recommendation.\n* Patient has neuroendocrine pancreatic tumor'}, 'identificationModule': {'nctId': 'NCT03060720', 'briefTitle': 'Systematic Hereditary Pancreatic Cancer Risk Assessment and Implications for Personalized Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Dana-Farber Cancer Institute'}, 'officialTitle': 'Systematic Hereditary Pancreatic Cancer Risk Assessment and Implications for Personalized Therapy', 'orgStudyIdInfo': {'id': '16-448'}, 'secondaryIdInfos': [{'id': 'P50CA127003', 'link': 'https://reporter.nih.gov/quickSearch/P50CA127003', 'type': 'NIH'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Matthew B Yurgelun, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dana-Farber Cancer Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dana-Farber Cancer Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Matthew B. Yurgelun, MD', 'investigatorFullName': 'Matthew B. Yurgelun, MD', 'investigatorAffiliation': 'Dana-Farber Cancer Institute'}}}}