The Cancer of the Pancreas Screening-5 CAPS5)Study (CAPS5)

  • STATUS
    Recruiting
  • End date
    Dec 24, 2025
  • participants needed
    7000
  • sponsor
    Johns Hopkins University
Updated on 24 May 2022
cancer
secretin
BRCA1
BRCA2
pancreatitis
palb2
fammm
ca19-9
synthetic secretin

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.

Details
Condition Pancreas Cancer, Peutz-Jeghers Syndrome (PJS), Gene Mutation, Germline Mutation Carrier, Lynch Syndrome
Treatment MRI, Human synthetic secretin, Secretin
Clinical Study IdentifierNCT02000089
SponsorJohns Hopkins University
Last Modified on24 May 2022

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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