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

Primary Purpose

Pancreas Cancer, Peutz-Jeghers Syndrome (PJS), Gene Mutation

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Secretin
MRI
Tumor marker gene test with CA19-9
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pancreas Cancer focused on measuring familial pancreas cancer, (Peutz-Jeghers Syndrome) PJS, Breast cancer (BRCA) 2, Partner and Locator of BRCA2 (PALB2), Familial Atypical Multiple Mole- Melanoma (FAMMM), p16, CDKN2A, 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)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Yale UniversityRecruiting
  • Johns Hopkins HospitalRecruiting
  • Dana Farber Cancer Center, Harvard UniversityRecruiting
  • University of MichiganRecruiting
  • Columbia University Medical CenterRecruiting
  • Case Comprehensive Cancer Center, Case Western Medical ReserveRecruiting
  • University of PennsylvaniaRecruiting
  • University of PittsburghRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Familial pancreas cancer relatives

Group 1 germline mutation carrier

Group 2 germline mutation carrier

Hereditary pancreatitis

Peutz-Jeghers Syndrome

Negative control

Chronic Pancreatitis

Pancreas cancer

Pancreas cyst, IPMN evaluation

Arm 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

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.

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.

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.

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

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)

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

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)

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).

Outcomes

Primary Outcome Measures

Evaluate pancreatic juice for early cancer markers.
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
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.

Full Information

First Posted
November 26, 2013
Last Updated
May 15, 2023
Sponsor
Johns Hopkins University
Collaborators
ChiRhoClin, Inc., National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02000089
Brief Title
The Cancer of the Pancreas Screening-5 CAPS5)Study
Acronym
CAPS5
Official Title
The Cancer of the Pancreas Screening-5 CAPS5)Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 6, 2014 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
ChiRhoClin, Inc., National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreas Cancer, Peutz-Jeghers Syndrome (PJS), Gene Mutation, Germline Mutation Carrier, Lynch Syndrome
Keywords
familial pancreas cancer, (Peutz-Jeghers Syndrome) PJS, Breast cancer (BRCA) 2, Partner and Locator of BRCA2 (PALB2), Familial Atypical Multiple Mole- Melanoma (FAMMM), p16, CDKN2A, 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)

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model Description
Evaluation of the effect of diagnostic tests for pancreatic cancer
Masking
None (Open Label)
Masking Description
No masking of the diagnostic test results
Allocation
Non-Randomized
Enrollment
7000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Familial pancreas cancer relatives
Arm Type
Active Comparator
Arm 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
Arm Title
Group 1 germline mutation carrier
Arm Type
Active Comparator
Arm 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): 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.
Arm Title
Group 2 germline mutation carrier
Arm Type
Active Comparator
Arm 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 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.
Arm Title
Hereditary pancreatitis
Arm Type
Active Comparator
Arm 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.
Arm Title
Peutz-Jeghers Syndrome
Arm Type
Active Comparator
Arm 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
Arm Title
Negative control
Arm Type
Active Comparator
Arm 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)
Arm Title
Chronic Pancreatitis
Arm Type
Active Comparator
Arm 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
Arm Title
Pancreas cancer
Arm Type
Active Comparator
Arm 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)
Arm Title
Pancreas cyst, IPMN evaluation
Arm Type
Active Comparator
Arm 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).
Intervention Type
Drug
Intervention Name(s)
Secretin
Other Intervention Name(s)
ChiRhoStim
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
MRI
Other Intervention Name(s)
MRCP
Intervention Description
MRI abdomen with contrast (MRCP) will be clinically indicated for abnormal novel CA-19-9 lab results.
Intervention Type
Other
Intervention Name(s)
Tumor marker gene test with CA19-9
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluate pancreatic juice for early cancer markers.
Description
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.
Time Frame
10 years
Secondary Outcome Measure Information:
Title
Compare pancreas juice with pancreas cyst fluid
Description
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.
Time Frame
10 years
Other Pre-specified Outcome Measures:
Title
Time disease progression and prevalence
Description
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.
Time Frame
10 years
Title
Diagnostic performance of a tumor marker gene test for CA19-9 interpretation
Description
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.
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hilary Cosby, RN
Email
hcosby1@jhmi.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Goggins, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Scott Merenda, BSN
Phone
203-785-7019
Email
scott.merenda@yale.edu
First Name & Middle Initial & Last Name & Degree
James Farrell, MD
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hilary Cosby, RN, CGRN
Phone
410-502-2893
Email
hcosby1@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Michael Goggins, MD
First Name & Middle Initial & Last Name & Degree
Marcia I Canto, MD
Facility Name
Dana Farber Cancer Center, Harvard University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Blair
Phone
617-632-4788
Email
emily_blair@DFCI.Harvard.edu
First Name & Middle Initial & Last Name & Degree
Chinedu Ukaegbu
Email
chinedu_ukaegbu@dfci.harvard.edu
First Name & Middle Initial & Last Name & Degree
Sapna Syngal, MD
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erika Koeppe, MS
Phone
734-998-1274
Email
eskoeppe@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Elena Stoffel, MD
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tiffany Lam
Email
tl3141@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Fay Kastrinos, MD
Facility Name
Case Comprehensive Cancer Center, Case Western Medical Reserve
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara Heaton
Phone
216-844-7314
Email
Barbara.Heaton@UHhospitals.org
First Name & Middle Initial & Last Name & Degree
Wendy Brock, RN
Phone
216-844-3853
Email
wendy.Brock@UHhospitals.org
First Name & Middle Initial & Last Name & Degree
Amitabh Chak, MD
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maureen DeMarshall, RN
Phone
215-349-8546
Email
demarshm@mail.med.upenn.edu
First Name & Middle Initial & Last Name & Degree
Daniel Clay
Email
Daniel.Clay@Pennmedicine.upenn.edu
First Name & Middle Initial & Last Name & Degree
Bryson Katona, MD
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Decapite
Email
decapitec@upmc.edu
First Name & Middle Initial & Last Name & Degree
Nancy Abubaker
Email
abubakern@upmc.edu
First Name & Middle Initial & Last Name & Degree
Randall Brand, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34149034
Citation
Kumar S, Saumoy M, Oh A, Schneider Y, Brand RE, Chak A, Ginsberg GG, Kochman ML, Canto MI, Goggins MG, Hur C, Kastrinos F, Katona BW, Rustgi AK. Threshold Analysis of the Cost-effectiveness of Endoscopic Ultrasound in Patients at High Risk for Pancreatic Ductal Adenocarcinoma. Pancreas. 2021 Jul 1;50(6):807-814. doi: 10.1097/MPA.0000000000001835.
Results Reference
derived
PubMed Identifier
33161160
Citation
Kohi S, Macgregor-Das A, Dbouk M, Yoshida T, Chuidian M, Abe T, Borges M, Lennon AM, Shin EJ, Canto MI, Goggins M. Alterations in the Duodenal Fluid Microbiome of Patients With Pancreatic Cancer. Clin Gastroenterol Hepatol. 2022 Feb;20(2):e196-e227. doi: 10.1016/j.cgh.2020.11.006. Epub 2020 Nov 5.
Results Reference
derived
PubMed Identifier
31676359
Citation
Abe T, Koi C, Kohi S, Song KB, Tamura K, Macgregor-Das A, Kitaoka N, Chuidian M, Ford M, Dbouk M, Borges M, He J, Burkhart R, Wolfgang CL, Klein AP, Eshleman JR, Hruban RH, Canto MI, Goggins M. Gene Variants That Affect Levels of Circulating Tumor Markers Increase Identification of Patients With Pancreatic Cancer. Clin Gastroenterol Hepatol. 2020 May;18(5):1161-1169.e5. doi: 10.1016/j.cgh.2019.10.036. Epub 2019 Oct 30.
Results Reference
derived
PubMed Identifier
31197699
Citation
Canto MI, Kerdsirichairat T, Yeo CJ, Hruban RH, Shin EJ, Almario JA, Blackford A, Ford M, Klein AP, Javed AA, Lennon AM, Zaheer A, Kamel IR, Fishman EK, Burkhart R, He J, Makary M, Weiss MJ, Schulick RD, Goggins MG, Wolfgang CL. Surgical Outcomes After Pancreatic Resection of Screening-Detected Lesions in Individuals at High Risk for Developing Pancreatic Cancer. J Gastrointest Surg. 2020 May;24(5):1101-1110. doi: 10.1007/s11605-019-04230-z. Epub 2019 Jun 13.
Results Reference
derived

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The Cancer of the Pancreas Screening-5 CAPS5)Study

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