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NCT Number: NCT02000089

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 their site.

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Key information

Conditions

Pancreas Cancer Breast Diseases Breast Neoplasms Colonic Diseases Colorectal Neoplasms Colorectal Neoplasms, Hereditary Nonpolyposis Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities DNA Repair-Deficiency Disorders Digestive System Diseases Digestive System Neoplasms Dysplastic Nevus Syndrome Endocrine Gland Neoplasms Endocrine System Diseases Gastrointestinal Diseases Gastrointestinal Neoplasms Gene Mutation Genetic Diseases, Inborn Germline Mutation Carrier Hereditary Sensory and Autonomic Neuropathies Hereditary pancreatitis Heredodegenerative Disorders, Nervous System Hyperpigmentation Intestinal Diseases Intestinal Neoplasms Intestinal Polyposis Lentigo Lynch Syndrome Melanosis Metabolic Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplastic Syndromes, Hereditary Nervous System Diseases Nervous System Malformations Neurodegenerative Diseases Neuromuscular Diseases Nevi and Melanomas Nevus Nutritional and Metabolic Diseases Pancreatic Diseases Pancreatic Neoplasms Peripheral Nervous System Diseases Peutz-Jeghers Syndrome Peutz-Jeghers Syndrome (PJS) Pigmentation Disorders Polyneuropathies Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Yale University, New Haven, Connecticut, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Secretin

Drug

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.

Other names: ChiRhoStim

MRI

Diagnostic Test

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

Other names: MRCP

Tumor marker gene test with CA19-9

Other

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.

Primary outcomes

  1. Evaluate pancreatic juice for early cancer markers.

    Time frame: 10 years

    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.

Secondary outcomes

  1. Compare pancreas juice with pancreas cyst fluid

    Time frame: 10 years

    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.

Other outcomes

  1. Time disease progression and prevalence

    Time frame: 10 years

    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.

  2. Diagnostic performance of a tumor marker gene test for CA19-9 interpretation

    Time frame: 5 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hilary Cosby, RN

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

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

Registry information

Acronym: CAPS5

Important dates

Study start
2014
Primary completion
2028
Study completion
2029
First posted
Dec 3, 2013
Registry last updated
Oct 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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