A Pancreatic Cancer Screening Study in Hereditary High Risk Individuals
Recruiting · NCT03250078 · Observational (researchers observe without assigning treatment) · Lead sponsor: Nuvance Health
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 Resonance Imaging and Magnetic cholangiopancreatography (MRI/MRCP) will be utilized to screen for early stage pancreatic cancer or precursor lesions. Participants will be asked to donate a blood sample at specific intervals for the creation of a bio-bank necessary for the development of a blood based screening test for Pancreatic Cancer.
Who can take part
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.
Where it is running
1 location listed across 1 US state.
- Nuvance Health - Norwalk, Connecticut, United States