RecruitingPhase 3NCT02000089

The Cancer of the Pancreas Screening-5 CAPS5)Study

Sponsor

Johns Hopkins University

Enrollment

9,000 participants

Start Date

Jan 6, 2014

Study Type

INTERVENTIONAL

Conditions

Pancreas Cancer Peutz-Jeghers Syndrome (PJS)Gene Mutation Germline Mutation Carrier Lynch Syndrome

Summary

Johns Hopkins clinical research office quality assurance group will monitor and audit this study at Johns Hopkins. The Sub Investigator at each site will be responsible for internal monitoring at their site.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is tracking high-risk individuals over time using endoscopic ultrasound and other tools to catch pancreatic cancer as early as possible — when treatment is most effective. You may be eligible if: - You have hereditary pancreatitis (a genetic form of recurring pancreas inflammation) - You have Peutz-Jeghers Syndrome (a condition involving special type of polyps and increased cancer risk) - You have a strong family history of pancreatic cancer on one side of your family - You carry a known gene change that raises pancreatic cancer risk (such as BRCA2, BRCA1, PALB2, ATM, CDKN2A, Lynch Syndrome genes, PRSS1, SPINK1, CFTR, or others) - You are scheduled for an endoscopic evaluation of the pancreas You may NOT be eligible if: - You have health problems that make it unsafe to have an endoscopy (like a bleeding disorder) - You have had stomach surgery (such as a gastrectomy or gastric bypass) that would make the endoscope hard to pass - You have a blockage in your upper digestive tract - Your overall health is too poor to safely complete the procedure - You are pregnant - You are not able to give your own consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSecretin

inject Secretin to stimulate pancreatic digestive fluid, which is collected in duodenum near ampulla via endoscope suction port. This fluid will be assessed for biomarkers.

DIAGNOSTIC_TESTMRI

MRI abdomen with contrast (MRCP) will be clinically indicated for abnormal novel CA-19-9 lab results.

OTHERTumor marker gene test with CA19-9

A tumor marker gene test that will be used to stratify individuals into one of several circulating tumor marker reference ranges for CA19-9. The variants in the genes FUT3 and FUT2 affect the levels of CA19-9.