Status:
RECRUITING
A Pancreatic Cancer Screening Study in Hereditary High Risk Individuals
Lead Sponsor:
Nuvance Health
Conditions:
Pancreatic Neoplasms
Eligibility:
All Genders
50-90 years
Brief Summary
The main goal of this study is to screen and detect pancreatic cancer and precursor lesions in individuals with a strong family history or genetic predisposition to pancreatic cancer. Magnetic Resonan...
Detailed Description
Individuals 50 years of age and older who have a family history of pancreatic cancer will be recruited through the offices of primary care physicians and endocrinologists. Those meeting initial criter...
Eligibility Criteria
Inclusion
- Registration-Inclusion Criteria for FAMILIAL PANCREATIC CANCER (FPC) and those with a BRCA1, BRCA2, LYNCH SYNDROME, ATM, PALB2, CDKN2A, or related gene mutation (one of the following is required for questions 1-3)
- For FPC: The individual has at least 2 first-degree relatives (FDR) with PC.
- For FPC: The individual has at least 3 first-, second-, or third-degree relatives with PC with at least 1 PC in a FDR.
- The individual is a known mutation carrier of BRCA1, BRCA2, MLH1, MSH2, MSH6, or PMS2, ATM, PALB2, CDKN2A, or similar high-risk gene mutation and has at least 1 first- or second-degree relative with PC.
- The individual is at least 50 years old or 10 years younger than the youngest relative with PC.
- ECOG Performance Status of 0-1.
- No known contraindications to MRI examination or gadolinium contrast.
- Willing to undergo MRI and screening for metal implants or metal injury.
- Estimated GFR \>29 mL/min
- Ability to provide informed consent.
- Willing to return to study site for all study assessments.
- Registration-Exclusion Criteria:
- Prior history of pancreatic cancer.
- Presence of metastatic cancer or cancer requiring adjuvant chemotherapy within the past 5 years.
- Received chemotherapy within the past 6 months. (Hormonal therapy is allowable if the disease free interval is at least 5 years).
- Hereditary pancreatitis.
- eGFR \< 30 mL/min
- Contraindication to MRI examination or gadolinium contrast.
- Pregnant or nursing women.
- Co-morbid illnesses or other concurrent disease which, in the judgment of the clinicians obtaining informed consent, would make the participant inappropriate for entry into this study.
Exclusion
Key Trial Info
Start Date :
November 1 2016
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03250078
Start Date
November 1 2016
End Date
November 1 2026
Last Update
April 1 2024
Active Locations (1)
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1
Nuvance Health
Norwalk, Connecticut, United States, 06856