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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 : December 7, 2017
Sponsor:
Collaborator:
ChiRhoClin, Inc.
Information provided by (Responsible Party):
Johns Hopkins University

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Pancreas Cancer Peutz-Jeghers Syndrome (PJS) Gene Mutation Germline Mutation Carrier Lynch Syndrome Drug: Human synthetic secretin

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 Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Observational
Estimated Enrollment : 2500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Cancer of the Pancreas Screening-5 CAPS5)Study
Study Start Date : January 2014
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
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 or more pancreatic cancer diagnoses 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, ATM 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 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: 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


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Evaluate pancreatic juice for early cancer markers. [ Time Frame: 8 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: 8 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: 8 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.


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)

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Contact: Hilary Cosby, RN hcosby1@jhmi.edu

Locations
United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06520
Contact: Barbara Clerkin, RN       Barbara.Clerkin@YNHH.ORG   
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: Audrey Madigan       AudreyP_Madigan@DFCI.Harvard.edu   
Contact: Chinedu Ukaegbu       chinedu_ukaegbu@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, New York, United States, 10032
Contact: Fay Kastrinos, MD       fk18@cumc.columbia.edu   
Sub-Investigator: Fay Kastrinos, MD         
United States, Ohio
Case Comprehensive Cancer Center, Case Western Medical Reserve Recruiting
Cleveland, Ohio, United States
Contact: Nancy Furrey, RN    216-844-7314    nancy.furey@uhhospitals.org   
Sub-Investigator: Amitabh Chak, MD         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States
Contact: Maureen DeMarshall, RN    215-349-8546    demarshm@mail.med.upenn.edu   
Contact: Diego Rodriguez       diego.rodriguez@uphs.upenn.edu   
Sub-Investigator: Anil Rustgi, MD         
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Beth Dudley       dudleyre@mail.magee.edu   
Contact: Randall 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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02000089     History of Changes
Other Study ID Numbers: NA_00087754
First Posted: December 3, 2013    Key Record Dates
Last Update Posted: December 7, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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
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:
Syndrome
Pancreatic Neoplasms
Colorectal Neoplasms, Hereditary Nonpolyposis
Peutz-Jeghers 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
Pancrelipase