The Cancer of the Pancreas Screening-5 CAPS5)Study

Sponsor
Johns Hopkins University (Other)
Overall Status
Recruiting
CT.gov ID
NCT02000089
Collaborator
ChiRhoClin, Inc. (Industry), National Cancer Institute (NCI) (NIH)
7,000
8
9
142.8
875
6.1

Study Details

Study Description

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
  • 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

Study Type:
Interventional
Anticipated Enrollment :
7000 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
Evaluation of the effect of diagnostic tests for pancreatic cancerEvaluation 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 :
Jan 6, 2014
Anticipated Primary Completion Date :
Oct 1, 2024
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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: 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 Names:
  • ChiRhoStim
  • Diagnostic Test: MRI
    MRI abdomen with contrast (MRCP) will be clinically indicated for abnormal novel CA-19-9 lab results.
    Other Names:
  • 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 Names:
  • ChiRhoStim
  • Diagnostic Test: MRI
    MRI abdomen with contrast (MRCP) will be clinically indicated for abnormal novel CA-19-9 lab results.
    Other Names:
  • 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%): > 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 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 Names:
  • ChiRhoStim
  • Diagnostic Test: MRI
    MRI abdomen with contrast (MRCP) will be clinically indicated for abnormal novel CA-19-9 lab results.
    Other Names:
  • 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 Names:
  • ChiRhoStim
  • Diagnostic Test: MRI
    MRI abdomen with contrast (MRCP) will be clinically indicated for abnormal novel CA-19-9 lab results.
    Other Names:
  • 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

    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: 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 Names:
  • ChiRhoStim
  • Diagnostic Test: MRI
    MRI abdomen with contrast (MRCP) will be clinically indicated for abnormal novel CA-19-9 lab results.
    Other Names:
  • 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

    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)

    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 Names:
  • ChiRhoStim
  • Active Comparator: 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: 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 Names:
  • 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 Names:
  • 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 Names:
  • ChiRhoStim
  • Outcome Measures

    Primary Outcome Measures

    1. Evaluate pancreatic juice for early cancer markers. [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 [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 [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 [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

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Yale University New Haven Connecticut United States 06520
    2 Johns Hopkins Hospital Baltimore Maryland United States 21287
    3 Dana Farber Cancer Center, Harvard University Boston Massachusetts United States 02215
    4 University of Michigan Ann Arbor Michigan United States 48109
    5 Columbia University Medical Center New York New York United States 10032
    6 Case Comprehensive Cancer Center, Case Western Medical Reserve Cleveland Ohio United States 44106
    7 University of Pennsylvania Philadelphia Pennsylvania United States 19104
    8 University of Pittsburgh Pittsburgh Pennsylvania United States 15213

    Sponsors and Collaborators

    • Johns Hopkins University
    • ChiRhoClin, Inc.
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Michael Goggins, MD, Johns Hopkins University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Johns Hopkins University
    ClinicalTrials.gov Identifier:
    NCT02000089
    Other Study ID Numbers:
    • NA_00087754
    • 1U01CA210170-01
    First Posted:
    Dec 3, 2013
    Last Update Posted:
    Aug 18, 2022
    Last Verified:
    Aug 1, 2022

    Study Results

    No Results Posted as of Aug 18, 2022