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RecruitingInterventionalPhase 3

The Cancer of the Pancreas Screening-5 CAPS5)Study

NCT ID: NCT02000089Sponsor: Johns Hopkins UniversityLast updated: 2025-10-09

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.

Arms & interventions

  • DrugSecretin

    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.

  • Diagnostic TestMRI

    MRI abdomen with contrast (MRCP) will be clinically indicated for abnormal novel CA-19-9 lab results.

  • OtherTumor 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.

Outcome measures

Primary

  • 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.

    Time frame: 10 years

Secondary

  • Compare pancreas juice with pancreas cyst fluid

    Time frame: 10 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy 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 (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.

Study locations (9)

Yale University

New Haven, Connecticut, 06520

Recruiting
Scott Merenda, BSN · Contact
203-785-7019scott.merenda@yale.edu
James Farrell, MD · Principal Investigator

Johns Hopkins Hospital

Baltimore, Maryland, 21287

Recruiting
Hilary Cosby, RN, CGRN · Contact
410-502-2893hcosby1@jhmi.edu
Michael Goggins, MD · Principal Investigator
Marcia I Canto, MD · Sub Investigator

Dana Farber Cancer Center, Harvard University

Boston, Massachusetts, 02215

Recruiting
Samantha Kuney · Contact
617-632-4788Samantha_Kuney@dfci.harvard.edu
Ethan Provost · Contact
ethan_provost@dfci.harvard.edu
Sapna Syngal, MD · Principal Investigator
Matthew Yurgelun, MD · Sub Investigator

University of Michigan

Ann Arbor, Michigan, 48109

Recruiting
Sarah Volk · Contact
734-998-1274stomanic@med.umich.edu
Elena Stoffel, MD · Sub Investigator

NYU Langone Medical Center

New York, New York, 10016

Recruiting
Emil Agarunov · Contact
emil.agarunov@nyulangone.org
Tamas Gonda, MD · Principal Investigator

Columbia University Medical Center

New York, New York, 10032

Recruiting
Katharine Godfrey · Contact
kb3217@cumc.columbia.edu
Fay Kastrinos, MD · Principal Investigator

Case Comprehensive Cancer Center, Case Western Medical Reserve

Cleveland, Ohio, 44106

Recruiting
Barbara Heaton · Contact
216-844-7314Barbara.Heaton@UHhospitals.org
Wendy Brock, RN · Contact
216-844-3853wendy.Brock@UHhospitals.org
Amitabh Chak, MD · Sub Investigator

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

Recruiting
Daniel Clay · Contact
215-360-0905Daniel.Clay@Pennmedicine.upenn.edu
Sara Karley · Contact
sara.karley@pennmedicine.upenn.edu
Bryson Katona, MD · Sub Investigator

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213

Recruiting
Christine Decapite · Contact
decapitec@upmc.edu
Sara Booz · Contact
boozs@upmc.edu
Randall Brand, MD · Principal Investigator

References

  • 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.(PubMed)
  • 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.(PubMed)
  • 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.(PubMed)
  • 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.(PubMed)