International Multicenter Registry of Cancer of the Pancreas Screening
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 17-002664
Sponsor Protocol Number: 17-002664
About this study
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To determine whether a surveillance program consisting of in a cohort of high-risk individuals results in an excess number of detected and surgically resected high-grade premalignant lesions and early stage pancreatic cancers compared to the natural disease development and manifestation.
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To determine whether above mentioned strategy results in an improved survival
compared to high-risk individuals not under surveillance and compared to the survival
statistics of sporadic pancreatic cancer.
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To determine patient and lesion characteristics by which precursor lesions can be stratified according their risk of malignant transformation.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Two or more affected blood relatives with PC, with at least one affected FDR
- Peutz-Jeghers syndrome (STK11 mutation or clinical diagnosis), regardless of family history
- p16 mutation carrier with ≥ 1 PC affected FDR
- BRCA2 mutation carrier with ≥ 1 PC affected FDR or two or more affected blood relatives
- PALB2 mutation carrier with ≥ 1 PC affected FDR
- Lynch syndrome with ≥ 1 PC affected FDR
- 50 years of age or 10 years younger than the youngest PC case in the family
Exclusion Criteria:
- Personal history of pancreatic cancer
- Younger than 18 years of age
- Older than 75 years of age
- Unable to provide informed consent either due to mental retardation or a language barrier
- Upper gastrointestinal tract obstruction or stricture that does not allow passage of an echoendoscope
- Severe medical illness; (ASA score ≥ 3)
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
Mayo Clinic Location |
Status |
|
Jacksonville, Fla.
Mayo Clinic principal investigator Michael Wallace, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available