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

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ClinicalTrials.gov Identifier: NCT02000089

Recruitment Status : Recruiting

First Posted : December 3, 2013

Last Update Posted : March 18, 2024

See Contacts and Locations

View this study on the modernized ClinicalTrials.gov

Sponsor:

Collaborators:

ChiRhoClin, Inc.

National Cancer Institute (NCI)

National Institutes of Health (NIH)

Information provided by (Responsible Party):

Johns Hopkins University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pancreas Cancer Peutz-Jeghers Syndrome (PJS) Gene Mutation Germline Mutation Carrier Lynch Syndrome	Drug: Secretin Diagnostic Test: MRI Other: Tumor marker gene test with CA19-9	Phase 3

Detailed 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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	7000 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Intervention Model Description:	Evaluation of the effect of diagnostic tests for pancreatic cancer
Masking:	None (Open Label)
Masking Description:	No masking of the diagnostic test results
Primary Purpose:	Diagnostic
Official Title:	The Cancer of the Pancreas Screening-5 CAPS5)Study
Actual Study Start Date :	January 6, 2014
Estimated Primary Completion Date :	October 2024
Estimated Study Completion Date :	December 2025

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Lynch syndrome Peutz-Jeghers syndrome

MedlinePlus related topics: Pancreatic Cancer

Genetic and Rare Diseases Information Center resources: Pancreatic Cancer Hereditary Pancreatitis Ataxia Telangiectasia Peutz-Jeghers Syndrome

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Familial pancreas cancer relatives High Risk Group 2 (familial pancreatic cancer relatives): > 55 years old or 10 years younger than the age of youngest relative with pancreatic cancer, and 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 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 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 Name: ChiRhoStim Diagnostic Test: MRI MRI abdomen with contrast (MRCP) will be clinically indicated for abnormal novel CA-19-9 lab results. Other Name: MRCP Other: Tumor marker gene test with CA19-9 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.
Active Comparator: Group 1 germline mutation carrier 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 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 Name: ChiRhoStim Diagnostic Test: MRI MRI abdomen with contrast (MRCP) will be clinically indicated for abnormal novel CA-19-9 lab results. Other Name: MRCP Other: Tumor marker gene test with CA19-9 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.
Active Comparator: Group 2 germline mutation carrier High Risk Group 4 (Group 2 germline mutation carriers with an associated with an estimated lifetime risk of pancreatic cancer of ~5%): > 50 years old or 10 years younger than the age of the youngest relative with pancreatic cancer, and 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 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 Name: ChiRhoStim Diagnostic Test: MRI MRI abdomen with contrast (MRCP) will be clinically indicated for abnormal novel CA-19-9 lab results. Other Name: MRCP Other: Tumor marker gene test with CA19-9 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.
Active Comparator: Hereditary pancreatitis 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 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 Name: ChiRhoStim Diagnostic Test: MRI MRI abdomen with contrast (MRCP) will be clinically indicated for abnormal novel CA-19-9 lab results. Other Name: MRCP Other: Tumor marker gene test with CA19-9 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.
Active Comparator: Peutz-Jeghers Syndrome At least 30 years old, and 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, known STK11 gene mutation carrier	Drug: Secretin 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 Name: ChiRhoStim Diagnostic Test: MRI MRI abdomen with contrast (MRCP) will be clinically indicated for abnormal novel CA-19-9 lab results. Other Name: MRCP Other: Tumor marker gene test with CA19-9 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.
Active Comparator: Negative control 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 have no clinical or radiologic suspicion of pancreatic disease (chronic pancreatitis or pancreatic cancer)	Drug: Secretin 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 Name: ChiRhoStim
Active Comparator: Chronic Pancreatitis 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, have no clinical or radiologic suspicion of pancreatic cancer	Drug: Secretin 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 Name: ChiRhoStim
Active Comparator: Pancreas cancer 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 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 Name: ChiRhoStim
Active Comparator: Pancreas cyst, IPMN evaluation 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 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 Name: ChiRhoStim

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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 Outcome Measures:

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.
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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02000089

Contacts

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Contact: Hilary Cosby, RN		hcosby1@jhmi.edu

Locations

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United States, Connecticut
Yale University	Recruiting
New Haven, Connecticut, United States, 06520
Contact: Scott Merenda, BSN 203-785-7019 scott.merenda@yale.edu
Principal Investigator: James Farrell, MD
United States, Maryland
Johns Hopkins Hospital	Recruiting
Baltimore, Maryland, United States, 21287
Contact: Hilary Cosby, RN, CGRN 410-502-2893 hcosby1@jhmi.edu
Principal Investigator: Michael Goggins, MD
Sub-Investigator: Marcia I Canto, MD
United States, Massachusetts
Dana Farber Cancer Center, Harvard University	Recruiting
Boston, Massachusetts, United States, 02215
Contact: Emily Blair 617-632-4788 emily_blair@DFCI.Harvard.edu
Contact: Chinedu Ukaegbu chinedu_ukaegbu@dfci.harvard.edu
Principal Investigator: Sapna Syngal, MD
United States, Michigan
University of Michigan	Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Erika Koeppe, MS 734-998-1274 eskoeppe@med.umich.edu
Sub-Investigator: Elena Stoffel, MD
United States, New York
Columbia University Medical Center	Recruiting
New York, New York, United States, 10032
Contact: Tiffany Lam tl3141@cumc.columbia.edu
Principal Investigator: Fay Kastrinos, MD
United States, Ohio
Case Comprehensive Cancer Center, Case Western Medical Reserve	Recruiting
Cleveland, Ohio, United States, 44106
Contact: Barbara Heaton 216-844-7314 Barbara.Heaton@UHhospitals.org
Contact: Wendy Brock, RN 216-844-3853 wendy.Brock@UHhospitals.org
Sub-Investigator: Amitabh Chak, MD
United States, Pennsylvania
University of Pennsylvania	Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Maureen DeMarshall, RN 215-349-8546 demarshm@mail.med.upenn.edu
Contact: Daniel Clay Daniel.Clay@Pennmedicine.upenn.edu
Sub-Investigator: Bryson Katona, MD
University of Pittsburgh	Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Christine Decapite decapitec@upmc.edu
Contact: Sara Booz boozs@upmc.edu
Principal Investigator: Randall Brand, MD

Sponsors and Collaborators

Johns Hopkins University

ChiRhoClin, Inc.

National Cancer Institute (NCI)

National Institutes of Health (NIH)

Investigators

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Principal Investigator:	Michael Goggins, MD	Johns Hopkins University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

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.

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.

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Responsible Party:	Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT02000089
Other Study ID Numbers:	NA_00087754 1U01CA210170-01 ( U.S. NIH Grant/Contract ) R01CA176828 ( U.S. NIH Grant/Contract )
First Posted:	December 3, 2013 Key Record Dates
Last Update Posted:	March 18, 2024
Last Verified:	March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Johns Hopkins University:


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)

Additional relevant MeSH terms:

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Pancreatic Neoplasms Colorectal Neoplasms, Hereditary Nonpolyposis Peutz-Jeghers Syndrome Syndrome Disease Pathologic Processes Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Colorectal Neoplasms Intestinal Neoplasms	Gastrointestinal Neoplasms Neoplastic Syndromes, Hereditary Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Genetic Diseases, Inborn DNA Repair-Deficiency Disorders Metabolic Diseases Intestinal Polyposis Lentigo Melanosis Hyperpigmentation Pigmentation Disorders Skin Diseases Secretin

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