Clinical trial · Interventional

The Cancer of the Pancreas Screening-5 CAPS5)Study

NCT02000089CI-TRIAL-00096438CAPS5recruitingPhase 3ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (5)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Gene Mutation	—	UNRESOLVED	—
Germline Mutation Carrier	—	UNRESOLVED	—
Lynch Syndrome	—	UNRESOLVED	—
Pancreas Cancer	Pancreatic Carcinoma	ALIAS	0.90
Peutz-Jeghers Syndrome (PJS)	—	UNRESOLVED	—

Interventions

Interventions (3)

Intervention	Type	Mapped drug	Match
MRI	Diagnostic Test	—	UNRESOLVED
Secretin	Drug	—	UNRESOLVED
Tumor marker gene test with CA19-9	Other	—	UNRESOLVED

Design

Arms and outcomes

Arms (9)

type
ACTIVE_COMPARATOR
label
Familial pancreas cancer relatives
description
High Risk Group 2 (familial pancreatic cancer relatives): 1. \> 55 years old or 10 years younger than the age of youngest relative with pancreatic cancer, and 2. 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 3. 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
interventionNames
1. Drug: Secretin
2. Diagnostic Test: MRI
3. Other: Tumor marker gene test with CA19-9
type
ACTIVE_COMPARATOR
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): 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.

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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 (CDKN2A/p16), PALB2, BRCA1, ATM, HNPCC, Lynch Syndrome (hMLH1, hMSH2, PMS2, hMSH6, EpCAM) PRSS1, PRSS2, R122H, N291l, SPINK1, CFTR
* 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.

References

Publications (4)

DERIVEDKumar 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. PMID 34149034
DERIVEDKohi 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. PMID 33161160
DERIVEDAbe 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. PMID 31676359
DERIVEDCanto 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. PMID 31197699

Registry

Dates and enrollment

Start: Jan 6, 2014
Primary completion: Dec 1, 2028
Completion: Jun 1, 2029
First posted: Dec 3, 2013
Last update posted: Oct 9, 2025
Enrollment: 9,000 (estimated)
Lead sponsor: Johns Hopkins University OTHER
Collaborators: National Cancer Institute (NCI); National Institutes of Health (NIH); American Association for Cancer Research
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)

Data updated 22 days agoSource updated Oct 9, 2025source: clinicaltrials

Locations

Locations by country (9)

Country	Sites	Recruiting
United States	9