The Cancer of the Pancreas Screening-5 CAPS5)Study - Full Text View

Purpose

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	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:

Genetics Home Reference related topics: Lynch syndrome Peutz-Jeghers syndrome hereditary pancreatitis

MedlinePlus related topics: Cancer Genes and Gene Therapy Pancreatic Cancer Pancreatitis

Drug Information available for: Pancreatin Pancrelipase

Genetic and Rare Diseases Information Center resources: Hereditary Pancreatitis Peutz-Jeghers Syndrome

U.S. FDA Resources

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): > 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: 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%): > 55 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: 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 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: 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 are undergoing EUS and/or 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: 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 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: 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

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
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	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: Rebecca Quinones Rebecca_Quinones@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 City, New York, United States, 10032
Contact: Melissa Terry mt2675@cumc.columbia.edu
Contact: Ashley McFarland alm2236@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
Sub-Investigator: Anil Rustgi, MD
University of Pittsburgh	Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Kara Golya keg18@pitt.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


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 7, 2016
Health Authority:	United States: Food and Drug Administration

Keywords provided by Johns Hopkins University:


familial pancreas cancer PJS BRCA2 PALB2 FAMMM p16	BRCA1 HNPCC Lynch Syndrome hereditary pancreatitis PRSS CTRC

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on September 29, 2016

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