The Cancer of the Pancreas Screening-5 CAPS5)Study

Pancreas Cancer Clinical Trial

— CAPS5  

Official title:

The Cancer of the Pancreas Screening-5 CAPS5)Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02000089
• Other study ID #: NA_00087754
• Secondary ID: 1U01CA210170-01R
• Status: Recruiting
• Phase: Phase 3
• Start date: January 6, 2014
• Est. completion date: December 2025

Study information

• Verified date: March 2024
• Source: Johns Hopkins University
• Contact: Hilary Cosby, RN
• Email: hcosby1[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 7000
• Est. completion date: December 2025
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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, PALB2, BRCA1, HNPCC, PRSS1/2, or CTRC
• 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.

Related Conditions & MeSH terms

• Colorectal Neoplasms, Hereditary Nonpolyposis
• Gene Mutation
• Germline Mutation Carrier
• Lynch Syndrome
• Pancreas Cancer
• Pancreatic Neoplasms
• Peutz-Jeghers Syndrome
• Peutz-Jeghers Syndrome (PJS)
• Syndrome

Intervention

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

Other:
• Tumor 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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	Dana Farber Cancer Center, Harvard University	Boston	Massachusetts
United States	Case Comprehensive Cancer Center, Case Western Medical Reserve	Cleveland	Ohio
United States	Yale University	New Haven	Connecticut
United States	Columbia University Medical Center	New York	New York
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
Johns Hopkins University	ChiRhoClin, Inc., National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time disease progression and prevalence	Aim #3: To determine the prevalence of pancreatic lesions, pancreatic fluid mutations and circulating pancreatic epithelial cells among a large cohort of high-risk individuals undergoing pancreatic screening and surveillance of a new cohort in which screening is begun at age >55.	10 years
Other	Diagnostic performance of a tumor marker gene test for CA19-9 interpretation	Aim #4 To evaluate the diagnostic performance of a tumor marker gene test to personalize the normal reference range of tumor markers such as CA19-9 for patients undergoing pancreatic surveillance.	5 years
Primary	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.	10 years
Secondary	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.	10 years