The Cancer of the Pancreas Screening-5 CAPS5)Study

Phase 3RecruitingNCT02000089

Johns Hopkins University9,000 enrolled

Overview

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.

The Sub Investigator at each site will be responsible for internal monitoring at their site. The site sub Investigator and study team will report any serious adverse events to Principal Investigator and annually report adverse events.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

9,000

Conditions

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

Interventions

SecretinDRUG

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.

MRIDIAGNOSTIC_TEST

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

Tumor marker gene test with CA19-9OTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Hereditary Pancreatitis or * Peutz-Jeghers Syndrome or * Strong family history of pancreas cancer on one side of the family tree or * Confirmed germline mutation carrier (BRCA2, FAMMM (CDKN2A/p16), PALB2, BRCA1, ATM, HNPCC, Lynch Syndrome (hMLH1, hMSH2, PMS2, hMSH6, EpCAM) PRSS1, PRSS2, R122H, N291l, SPINK1, CFTR * Endoscopic evaluation of pancreas scheduled Exclusion Criteria: * Medical comorbidities or coagulopathy that contraindicate endoscopy * Prior surgery that prevent optimal endoscopic ultrasound such as partial or complete gastrectomy with Bilroth or Roux-en-Y anastomosis * Stricture or obstruction in the upper GI tract that does not allow passage of the echoendoscope * Poor performance status * Inability to provide informed consent * Pregnancy.

Locations (9)

Yale University

New Haven, Connecticut, United States

RECRUITING

Johns Hopkins Hospital

Baltimore, Maryland, United States

RECRUITING

Outcomes

Primary Outcomes

Evaluate pancreatic juice for early cancer markers.

Aim #1: To evaluate pancreatic fluid mutations and circulating pancreatic epithelial cells as accurate markers of neoplasia by comparing their prevalence in cases with sporadic pancreatic neoplasia to healthy and disease controls.

Time frame: 10 years

Secondary Outcomes

Compare pancreas juice with pancreas cyst fluid

Aim #2: To compare the prevalence of pancreatic fluid mutations and circulating pancreatic epithelial cells among a prospective cohort of individuals with sporadic pancreatic cysts undergoing pancreatic surveillance.

Time frame: 10 years

Central Contacts

Hilary Cosby, RN

CONTACT

hcosby1@jhmi.edu

Data from ClinicalTrials.gov

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