The Cancer of the Pancreas Screening-5 CAPS5)Study

The Cancer of the Pancreas Screening-5 CAPS5)Study

Sponsors

Lead Sponsor: Johns Hopkins University

Collaborator: ChiRhoClin, Inc.
National Cancer Institute (NCI)

Source Johns Hopkins University
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.

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.

Overall Status Recruiting
Start Date January 2014
Completion Date December 2025
Primary Completion Date October 2024
Study Type Observational
Primary Outcome
Measure Time Frame
Evaluate pancreatic juice for early cancer markers. 10 years
Secondary Outcome
Measure Time Frame
Compare pancreas juice with pancreas cyst fluid 10 years
Enrollment 3000
Condition
Intervention

Intervention Type: Drug

Intervention Name: Human synthetic secretin

Description: I.V. bolus of 0.2 mcg/kg secretin given to induce pancreas juice secretion. This intervention offered for all cohorts

Eligibility

Sampling Method: Probability Sample

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Michael Goggins, MD Principal Investigator Johns Hopkins University
Overall Contact

Last Name: Hilary Cosby, RN

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Investigator:
Yale University | New Haven, Connecticut, 06520, United States Recruiting Scott Merenda, BSN 203-785-7019 [email protected] James Farrell, MD Sub-Investigator
Johns Hopkins Hospital | Baltimore, Maryland, 21287, United States Recruiting Hilary Cosby, RN, CGRN 410-502-2893 [email protected] Michael Goggins, MD Principal Investigator
Dana Farber Cancer Center, Harvard University | Boston, Massachusetts, 02215, United States Recruiting Brigette Rankin 617-632-4788 [email protected] Sapna Syngal, MD Sub-Investigator
University of Michigan | Ann Arbor, Michigan, 48109, United States Recruiting Erika Koeppe, MS 734-998-1274 [email protected] Elena Stoffel, MD Sub-Investigator
Columbia University Medical Center | New York, New York, 10032, United States Recruiting Tanjina Razzaque [email protected] Fay Kastrinos, MD Sub-Investigator
Case Comprehensive Cancer Center, Case Western Medical Reserve | Cleveland, Ohio, 44106, United States Recruiting Nancy Furrey, RN 216-844-7314 [email protected] Amitabh Chak, MD Sub-Investigator
University of Pennsylvania | Philadelphia, Pennsylvania, 19104, United States Recruiting Maureen DeMarshall, RN 215-349-8546 [email protected] Anil Rustgi, MD Sub-Investigator
University of Pittsburgh | Pittsburgh, Pennsylvania, 15213, United States Recruiting Beth Dudley [email protected] Randy Brand, MD Sub-Investigator
Location Countries

United States

Verification Date

June 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: Familial pancreas cancer relatives

Description: 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

Label: Group 1 germline mutation carrier

Description: High Risk Group 3 (Group 1 germline mutation carriers with an associated with an estimated lifetime risk of pancreatic cancer of ~10% or higher): > 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 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. The Patient is a carrier of a confirmed FAMMM (p16/CDKN2A), age 40 years or older, regardless of family history of pancreas cancer.

Label: Group 2 germline mutation carrier

Description: 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, 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.

Label: Hereditary pancreatitis

Description: 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.

Label: Peutz-Jeghers Syndrome

Description: 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

Label: Negative control

Description: 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)

Label: Chronic Pancreatitis

Description: 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

Label: Pancreas cancer

Description: 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)

Label: Pancreas cyst, IPMN evaluation

Description: 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).

Acronym CAPS5
Patient Data No
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov