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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02000089
Recruitment Status : Recruiting
First Posted : December 3, 2013
Last Update Posted : May 17, 2023
Sponsor:
Collaborators:
ChiRhoClin, Inc.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Johns Hopkins University

Study Description
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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


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Familial pancreas cancer relatives

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
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%):

  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
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
  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
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
  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
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
  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
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
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Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
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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: Nancy Abubaker       abubakern@upmc.edu   
Principal Investigator: Randall Brand, MD         
Sponsors and Collaborators
Johns Hopkins University
ChiRhoClin, Inc.
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Michael Goggins, MD Johns Hopkins University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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 )
First Posted: December 3, 2013    Key Record Dates
Last Update Posted: May 17, 2023
Last Verified: May 2023
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