A Pancreatic Cancer Screening Study in Hereditary High Risk Individuals (NCT03250078) | Clinical Trial Compass
RecruitingNot Applicable
A Pancreatic Cancer Screening Study in Hereditary High Risk Individuals
United States200 participantsStarted 2016-11
Plain-language 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 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 participate
Age range50 Years – 90 Years
SexALL
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Inclusion criteria
✓. 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
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.
✕
What they're measuring
1
Early Stage Pancreatic Cancer or Precursor Lesions
Timeframe: Through study completion, up to 3 years
✕. 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.