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The Cancer of the Pancreas Screening-5 CAPS5)Study | Clinical Trials | Clareo Health

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RECRUITINGPhase 3NCT02000089

The Cancer of the Pancreas Screening-5 CAPS5)Study

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 thei...

Lead sponsor: Johns Hopkins University•9 U.S. locations•View source on ClinicalTrials.gov

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Contacts

Hilary Cosby, RN

CONTACT

[email protected]

Sponsors

Lead Sponsor

Johns Hopkins University

Collaborators

National Cancer Institute (NCI)
National Institutes of Health (NIH)
American Association for Cancer Research

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.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: October 9, 2025Terms

Trial snapshot

StatusRECRUITING

PhasePHASE3

Enrollment9,000

Start dateJan 2014

Last updatedOct 9, 2025

Condition

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

Locations shown

Yale University

New Haven, Connecticut

Johns Hopkins Hospital

Baltimore, Maryland

Dana Farber Cancer Center, Harvard University

Boston, Massachusetts

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 9, 2025Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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