The Cancer of the Pancreas Screening-5 CAPS5)Study (CAPS5)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02000089 |
Recruitment Status :
Recruiting
First Posted : December 3, 2013
Last Update Posted : November 24, 2020
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Condition or disease | Intervention/treatment |
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Pancreas Cancer Peutz-Jeghers Syndrome (PJS) Gene Mutation Germline Mutation Carrier Lynch Syndrome | Drug: Human synthetic secretin |
Study Type : | Observational |
Estimated Enrollment : | 3000 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 2024 |
Estimated Study Completion Date : | December 2025 |

Group/Cohort | Intervention/treatment |
---|---|
Familial pancreas cancer relatives
High Risk Group 2 (familial pancreatic cancer relatives):
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):
|
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%):
|
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.
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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
|
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
|
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
|
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 |
- Evaluate pancreatic juice for early cancer markers. [ Time Frame: 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.
- Compare pancreas juice with pancreas cyst fluid [ Time Frame: 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.
- Time disease progression and prevalence [ Time Frame: 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.
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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.

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
Contact: Hilary Cosby, RN | hcosby1@jhmi.edu |
United States, Connecticut | |
Yale University | Recruiting |
New Haven, Connecticut, United States, 06520 | |
Contact: Scott Merenda, BSN 203-785-7019 scott.merenda@yale.edu | |
Contact: James Farrell, MD james.j.farrell@yale.edu | |
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, 02215 | |
Contact: Brigette Rankin 617-632-4788 BrigetteE_Rankin@DFCI.HARVARD.EDU | |
Contact: Chinedu Ukaegbu chinedu_ukaegbu@dfci.harvard.edu | |
Sub-Investigator: Sapna Syngal, MD | |
United States, Michigan | |
University of Michigan | Recruiting |
Ann Arbor, Michigan, United States, 48109 | |
Contact: Erika Koeppe, MS 734-998-1274 eskoeppe@med.umich.edu | |
Sub-Investigator: Elena Stoffel, MD | |
United States, New York | |
Columbia University Medical Center | Recruiting |
New York, New York, United States, 10032 | |
Contact: Tanjina Razzaque tr2432@cumc.columbia.edu | |
Sub-Investigator: Fay Kastrinos, MD | |
United States, Ohio | |
Case Comprehensive Cancer Center, Case Western Medical Reserve | Recruiting |
Cleveland, Ohio, United States, 44106 | |
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, 19104 | |
Contact: Maureen DeMarshall, RN 215-349-8546 demarshm@mail.med.upenn.edu | |
Sub-Investigator: Bryson Katona, 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 |
Principal Investigator: | Michael Goggins, MD | Johns Hopkins University |
Responsible Party: | Johns Hopkins University |
ClinicalTrials.gov Identifier: | NCT02000089 |
Other Study ID Numbers: |
NA_00087754 1U01CA210170-01 ( U.S. NIH Grant/Contract ) |
First Posted: | December 3, 2013 Key Record Dates |
Last Update Posted: | November 24, 2020 |
Last Verified: | November 2020 |
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 |
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) |
Pancreatic Neoplasms Colorectal Neoplasms, Hereditary Nonpolyposis Peutz-Jeghers Syndrome 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 Secretin |