The Cancer of the Pancreas Screening-5 CAPS5)Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Johns Hopkins University
Sponsor:
Collaborator:
ChiRhoClin, Inc.
Information provided by (Responsible Party):
Michael Goggins, MD, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT02000089
First received: November 26, 2013
Last updated: September 10, 2014
Last verified: September 2014
  Purpose

Johns Hopkins clinical research office quality assurance group will monitor and audit this study at Johns Hopkins. The Principal Investigator at each site will be responsible for internal monitoring at their site.


Condition Intervention
Pancreas Cancer
Peutz-Jeghers Syndrome
Gene Mutation
Germline Mutation Carrier
Lynch Syndrome
Drug: Human synthetic secretin

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Cancer of the Pancreas Screening-5 CAPS5)Study

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Evaluate pancreatic juice for early cancer markers. [ Time Frame: 8 years ] [ Designated as safety issue: No ]
    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: 8 years ] [ Designated as safety issue: No ]
    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: 8 years ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples With DNA

approximately 40 ml of blood approximately 5-20 ml pancreas juice approximately 10 ml saliva (optional) pancreas cyst fluid (if available)


Estimated Enrollment: 2500
Study Start Date: January 2014
Estimated Study Completion Date: December 2023
Estimated Primary Completion Date: October 2021 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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: Human synthetic secretin
I.V. bolus of 0.2 mcg/kg secretin given to induce pancreas juice secretion. This intervention offered for all cohorts
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 with pancreatic cancer, and b. The Patient is a carrier of a confirmed FAMMM (p16/CDKN2A), BRCA2, or PALB2 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: Human synthetic secretin
I.V. bolus of 0.2 mcg/kg secretin given to induce pancreas juice secretion. This intervention offered for all cohorts
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. > 55 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: Human synthetic secretin
I.V. bolus of 0.2 mcg/kg secretin given to induce pancreas juice secretion. This intervention offered for all cohorts
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: Human synthetic secretin
I.V. bolus of 0.2 mcg/kg secretin given to induce pancreas juice secretion. This intervention offered for all cohorts
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: Human synthetic secretin
I.V. bolus of 0.2 mcg/kg secretin given to induce pancreas juice secretion. This intervention offered for all cohorts
Negative control
  1. are undergoing EUS and/or 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: Human synthetic secretin
I.V. bolus of 0.2 mcg/kg secretin given to induce pancreas juice secretion. This intervention offered for all cohorts
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: Human synthetic secretin
I.V. bolus of 0.2 mcg/kg secretin given to induce pancreas juice secretion. This intervention offered for all cohorts
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: Human synthetic secretin
I.V. bolus of 0.2 mcg/kg secretin given to induce pancreas juice secretion. This intervention offered for all cohorts
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: Human synthetic secretin
I.V. bolus of 0.2 mcg/kg secretin given to induce pancreas juice secretion. This intervention offered for all cohorts

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Individuals at elevated risk for developing pancreas cancer

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02000089

Contacts
Contact: Hilary Cosby, RN hcosby1@jhmi.edu

Locations
United States, Connecticut
Yale University Not yet recruiting
New Haven, Connecticut, United States
Contact: James Farrell, MD       james.j.farrell@yale.edu   
Sub-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         
United States, Massachusetts
Dana Farber Cancer Center, Harvard University Recruiting
Boston, Massachusetts, United States
Contact: Sapna Syngal, MD       sapna_syngal@dfci.harvard.edu   
Sub-Investigator: Sapna Syngal, MD         
United States, Michigan
University of Michigan Not yet recruiting
Ann Arbor, Michigan, United States
Contact: Andrew Rhim, MD       arhim@med.umich.edu   
Sub-Investigator: Andrew Rhim, MD         
United States, New York
Columbia University Medical Center Recruiting
New York City, New York, United States, 10032
Contact: Kay Kastrinos, MD       fk18@cumc.columbia.edu   
United States, Ohio
Case Comprehensive Cancer Center, Case Western Medical Reserve Recruiting
Cleveland, Ohio, United States
Contact: Amitabh Chak, MD       amitabh.chak@uhhospitals.org   
Sub-Investigator: Amitabh Chak, MD         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States
Contact: Anil Rustgi, MD       anil2@mail.med.upenn.edu   
Sub-Investigator: Anil Rustgi, MD         
University of Pittsburgh Not yet recruiting
Pittsburgh, Pennsylvania, United States
Contact: Randy Brand, MD       brandre@upmc.edu   
Sub-Investigator: Randy Brand, MD         
Sponsors and Collaborators
Johns Hopkins University
ChiRhoClin, Inc.
Investigators
Principal Investigator: Michael Goggins, MD Johns Hopkins University
  More Information

No publications provided

Responsible Party: Michael Goggins, MD, Professor of Medicine, Pathology and Gastroenterology, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02000089     History of Changes
Other Study ID Numbers: NA_00087754
Study First Received: November 26, 2013
Last Updated: September 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Johns Hopkins University:
hereditary pancreatitis
familial pancreas cancer
PJS
BRCA2
PALB2
FAMMM
p16
BRCA1
HNPCC
Lynch Syndrome
PRSS
CTRC

Additional relevant MeSH terms:
Syndrome
Pancreatic Neoplasms
Peutz-Jeghers Syndrome
Disease
Pathologic Processes
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
Lentigo
Melanosis
Hyperpigmentation
Pigmentation Disorders
Skin Diseases
Pancreatin
Pancrelipase
Secretin
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 30, 2014