The Cancer of the Pancreas Screening-5 CAPS5)Study

NCT02000089 | Recruiting Phase 3 FDA Drug

• 3 other identifiers: NA_000877541U01CA210170-01R01CA176828
• Study Type: interventional
• Target: 9,000
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

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

Keywords

familial pancreas cancer; (Peutz-Jeghers Syndrome) PJS; Breast cancer (BRCA) 2; Partner and Locator of BRCA2 (PALB2); Familial Atypical Multiple Mole- Melanoma (FAMMM); p16, CDKN2A; Breast Cancer (BRCA)1; (hereditary non-polyposis colorectal cancer or Lynch syndrome) HNPCC; Lynch Syndrome; hereditary pancreatitis; Protease Serine (PRSS); Chymotrypsin C (CTRC); Ataxia Telangiectasia Mutated(ATM)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Compare pancreas juice with pancreas cyst fluid

  10 years

Other Outcomes (2)

• Time disease progression and prevalence

  10 years

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

  5 years

Study Arms (9)

Familial pancreas cancer relatives

ACTIVE COMPARATOR

High Risk Group 2 (familial pancreatic cancer relatives): 1. \> 55 years old or 10 years younger than the age of youngest relative with pancreatic cancer, and 2. come from a family with 2 or more members with a history of pancreatic cancer (2 of which have a first-degree relationship consistent with familial pancreatic cancer), and 3. have a first-degree relationship with at least one of the relatives with pancreatic cancer. If there are 2 or more affected blood relatives, at least 1 must be a first-degree relative of the individual being screened

Drug: Secretin; Diagnostic Test: MRI; Other: Tumor marker gene test with CA19-9

Group 1 germline mutation carrier

ACTIVE COMPARATOR

High Risk Group 3 (Group 1 germline mutation carriers with an associated with an estimated lifetime risk of pancreatic cancer of \~10% or higher): a. \> 50 years old or 10 years younger than the age of the youngest relative affected, if pancreatic cancer is in family, and b. The Patient is a carrier of a confirmed BRCA2, ATM or PALB2 mutation, regardless of family history of pancreatic cancer. b.\> Individual is a carrier of a confirmed FAMMM (p16/CDKN2A) mutation, age 40 years or older, regardless of family history of pancreas cancer.

Drug: Secretin; Diagnostic Test: MRI; Other: Tumor marker gene test with CA19-9

Group 2 germline mutation carrier

ACTIVE COMPARATOR

High Risk Group 4 (Group 2 germline mutation carriers with an associated with an estimated lifetime risk of pancreatic cancer of \~5%): 1. \> 50 years old or 10 years younger than the age of the youngest relative with pancreatic cancer, and 2. The patient is a carrier of a confirmed BRCA1 or HNPCC (hereditary non-polyposis colorectal cancer or Lynch syndrome, hMLH1, hMSH2, PMS1, hMSH6, EpCAM) gene mutation, and there is \> 1 pancreatic cancer in the family, one of whom is a first- or second-degree relative of the subject to be screened.

Drug: Secretin; Diagnostic Test: MRI; Other: Tumor marker gene test with CA19-9

Hereditary pancreatitis

ACTIVE COMPARATOR

High risk group 5 (hereditary pancreatitis) with confirmed gene mutations that predispose to chronic pancreatitis, such as PRSS1, PRSS2, CTRC) and age 50 years or older (these patients have an estimated lifetime risk for pancreatic cancer of 40%) or twenty-years since their first attack of pancreatitis, whichever age is younger.

Drug: Secretin; Diagnostic Test: MRI; Other: Tumor marker gene test with CA19-9

Peutz-Jeghers Syndrome

ACTIVE COMPARATOR

1. At least 30 years old, and 2. at least 2 of 3 criteria diagnostic of Peutz-Jeghers syndrome (characteristic intestinal hamartomatous polyps, mucocutaneous melanin deposition, or family history of Peutz-Jeghers syndrome), or, 3. known STK11 gene mutation carrier

Drug: Secretin; Diagnostic Test: MRI; Other: Tumor marker gene test with CA19-9

Negative control

ACTIVE COMPARATOR

1. are undergoing routine EGD or Colonoscopy; or Endoscopic Ultrasound (EUS) and/or Endoscopic Retrograde Cholangiopancreatography (ERCP) for non-pancreatic indications as part of their standard medical care, and 2. have no clinical or radiologic suspicion of pancreatic disease (chronic pancreatitis or pancreatic cancer)

Drug: Secretin

Chronic Pancreatitis

ACTIVE COMPARATOR

1. are undergoing EUS and/or ERCP for evaluation and/or treatment of suspected or proven chronic pancreatitis as part of their standard medical care, and, 2. have no clinical or radiologic suspicion of pancreatic cancer

Drug: Secretin

Pancreas cancer

ACTIVE COMPARATOR

a. are undergoing EUS and/or ERCP for evaluation and/or treatment of suspected or proven pancreatic ductal adenocarcinoma (based on clinical and radiologic evidence)

Drug: Secretin

Pancreas cyst, IPMN evaluation

ACTIVE COMPARATOR

are undergoing EUS and/or ERCP for evaluation and/or treatment of suspected or proven pancreatic cancer precursor, intraductal papillary mucinous neoplasm (based on clinical presentation and radiologic or prior EUS or radiologic evidence of a dilated main pancreatic duct and/or pancreatic cystic lesion communicating with the pancreatic ductal system).

Drug: Secretin

Interventions

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.

Also known as: ChiRhoStim

Chronic Pancreatitis; Familial pancreas cancer relatives; Group 1 germline mutation carrier; Group 2 germline mutation carrier; Hereditary pancreatitis; Negative control; Pancreas cancer; Pancreas cyst, IPMN evaluation; Peutz-Jeghers Syndrome

MRI DIAGNOSTIC_TEST

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

Also known as: MRCP

Familial pancreas cancer relatives; Group 1 germline mutation carrier; Group 2 germline mutation carrier; Hereditary pancreatitis; Peutz-Jeghers Syndrome

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.

Familial pancreas cancer relatives; Group 1 germline mutation carrier; Group 2 germline mutation carrier; Hereditary pancreatitis; Peutz-Jeghers Syndrome

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Cancer Institute (NCI): collaborator
• National Institutes of Health (NIH): collaborator
• American Association for Cancer Research: collaborator

Study Sites (9)

Yale University

New Haven, Connecticut, 06520, United States

RECRUITING

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

RECRUITING

Dana Farber Cancer Center, Harvard University

Boston, Massachusetts, 02215, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

NYU Langone Medical Center

New York, New York, 10016, United States

RECRUITING

Columbia University Medical Center

New York, New York, 10032, United States

RECRUITING

Case Comprehensive Cancer Center, Case Western Medical Reserve

Cleveland, Ohio, 44106, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Related Publications (4)

• Kumar S, Saumoy M, Oh A, Schneider Y, Brand RE, Chak A, Ginsberg GG, Kochman ML, Canto MI, Goggins MG, Hur C, Kastrinos F, Katona BW, Rustgi AK. Threshold Analysis of the Cost-effectiveness of Endoscopic Ultrasound in Patients at High Risk for Pancreatic Ductal Adenocarcinoma. Pancreas. 2021 Jul 1;50(6):807-814. doi: 10.1097/MPA.0000000000001835.

  PMID: 34149034 DERIVED

• Kohi S, Macgregor-Das A, Dbouk M, Yoshida T, Chuidian M, Abe T, Borges M, Lennon AM, Shin EJ, Canto MI, Goggins M. Alterations in the Duodenal Fluid Microbiome of Patients With Pancreatic Cancer. Clin Gastroenterol Hepatol. 2022 Feb;20(2):e196-e227. doi: 10.1016/j.cgh.2020.11.006. Epub 2020 Nov 5.

  PMID: 33161160 DERIVED

• Abe T, Koi C, Kohi S, Song KB, Tamura K, Macgregor-Das A, Kitaoka N, Chuidian M, Ford M, Dbouk M, Borges M, He J, Burkhart R, Wolfgang CL, Klein AP, Eshleman JR, Hruban RH, Canto MI, Goggins M. Gene Variants That Affect Levels of Circulating Tumor Markers Increase Identification of Patients With Pancreatic Cancer. Clin Gastroenterol Hepatol. 2020 May;18(5):1161-1169.e5. doi: 10.1016/j.cgh.2019.10.036. Epub 2019 Oct 30.

  PMID: 31676359 DERIVED

• Canto MI, Kerdsirichairat T, Yeo CJ, Hruban RH, Shin EJ, Almario JA, Blackford A, Ford M, Klein AP, Javed AA, Lennon AM, Zaheer A, Kamel IR, Fishman EK, Burkhart R, He J, Makary M, Weiss MJ, Schulick RD, Goggins MG, Wolfgang CL. Surgical Outcomes After Pancreatic Resection of Screening-Detected Lesions in Individuals at High Risk for Developing Pancreatic Cancer. J Gastrointest Surg. 2020 May;24(5):1101-1110. doi: 10.1007/s11605-019-04230-z. Epub 2019 Jun 13.

  PMID: 31197699 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms; Peutz-Jeghers Syndrome; Colorectal Neoplasms, Hereditary Nonpolyposis; Breast Neoplasms; Dysplastic Nevus Syndrome; Hereditary pancreatitis; Hereditary Sensory and Autonomic Neuropathies

Interventions

Secretin; CA-19-9 Antigen

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Neoplastic Syndromes, Hereditary; Intestinal Polyposis; Intestinal Diseases; Gastrointestinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lentigo; Melanosis; Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Colonic Diseases; DNA Repair-Deficiency Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Breast Diseases; Nevus; Nevi and Melanomas; Neoplasms by Histologic Type; Nervous System Malformations; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Congenital Abnormalities

Intervention Hierarchy (Ancestors)

Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins; Antigens, Tumor-Associated, Carbohydrate; Antigens, Neoplasm; Antigens; Biological Factors; Lewis Blood Group Antigens; Blood Group Antigens; Antigens, Surface; Epitopes; Isoantigens; Biomarkers, Tumor; Biomarkers

Study Officials

• Michael Goggins, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hilary Cosby, RN

CONTACT

hcosby1@jhmi.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: No masking of the diagnostic test results
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Evaluation of the effect of diagnostic tests for pancreatic cancer

Study Record Dates

• First Submitted: November 26, 2013
• First Posted: December 3, 2013
• Study Start: January 6, 2014
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: October 9, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)