The Cancer of the Pancreas Screening-5 CAPS5)Study

Last updated: October 8, 2025
Sponsor: Johns Hopkins University
Overall Status: Active - Recruiting

Phase

3

Condition

Colon Cancer

Colorectal Cancer

Precancerous Condition

Treatment

Tumor marker gene test with CA19-9

MRI

Secretin

Clinical Study ID

NCT02000089
NA_00087754
1U01CA210170-01
R01CA176828
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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

Exclusion Criteria:

  • Medical comorbidities or coagulopathy that contraindicate endoscopy

  • Prior surgery that prevent optimal endoscopic ultrasound such as partial or completegastrectomy with Bilroth or Roux-en-Y anastomosis

  • Stricture or obstruction in the upper GI tract that does not allow passage of theechoendoscope

  • Poor performance status

  • Inability to provide informed consent

  • Pregnancy.

Study Design

Total Participants: 9000
Treatment Group(s): 3
Primary Treatment: Tumor marker gene test with CA19-9
Phase: 3
Study Start date:
January 06, 2014
Estimated Completion Date:
June 30, 2029

Study 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.

Connect with a study center

  • Yale University

    New Haven, Connecticut 06520
    United States

    Site Not Available

  • Yale University

    New Haven 4839366, Connecticut 4831725 06520
    United States

    Active - Recruiting

  • Johns Hopkins Hospital

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Johns Hopkins Hospital

    Baltimore 4347778, Maryland 4361885 21287
    United States

    Active - Recruiting

  • Dana Farber Cancer Center, Harvard University

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Dana Farber Cancer Center, Harvard University

    Boston 4930956, Massachusetts 6254926 02215
    United States

    Active - Recruiting

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • University of Michigan

    Ann Arbor 4984247, Michigan 5001836 48109
    United States

    Active - Recruiting

  • Columbia University Medical Center

    New York, New York 10032
    United States

    Active - Recruiting

  • NYU Langone Medical Center

    New York, New York 10016
    United States

    Site Not Available

  • Columbia University Medical Center

    New York City, New York 10032
    United States

    Site Not Available

  • Columbia University Medical Center

    New York 5128581, New York 5128638 10032
    United States

    Active - Recruiting

  • NYU Langone Medical Center

    New York 5128581, New York 5128638 10016
    United States

    Active - Recruiting

  • Case Comprehensive Cancer Center, Case Western Medical Reserve

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Case Comprehensive Cancer Center, Case Western Medical Reserve

    Cleveland 5150529, Ohio 5165418 44106
    United States

    Active - Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • University of Pittsburgh

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • University of Pennsylvania

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Active - Recruiting

  • University of Pittsburgh

    Pittsburgh 5206379, Pennsylvania 6254927 15213
    United States

    Active - Recruiting

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