Pancreas CancerPhase 3CAPS5NCT02000089
The Cancer of the Pancreas Screening-5 CAPS5)Study
A Phase 3 study testing Secretin, MRI and Tumor marker gene test with CA19-9 in people with Pancreas Cancer and Peutz-Jeghers Syndrome (PJS), run by Johns Hopkins University at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Cancer, Peutz-Jeghers Syndrome (PJS), Gene Mutation
- What is being tested?
- Secretin, MRI and Tumor marker gene test with CA19-9
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9,000 participants
- Where
- 9 sitesUnited States
- Study dates
- 6 Jan 2014to Jun 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Hilary Cosby, RN contact
9 sites in 1 country
United States9 sites, 9 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Sarah Volk, 734-998-1274, stomanic@med.umich.edu
Elena Stoffel, MD
- Recruiting
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Hilary Cosby, RN, CGRN, 410-502-2893, hcosby1@jhmi.edu
Michael Goggins, MD
- Recruiting
Dana Farber Cancer Center, Harvard University
Boston, Massachusetts, 02215
Isabelle Flaherty, 617-582-7938, Isabelle_flaherty@dfci.harvard.edu
Ethan Provost, 617-632-4788, ethan_provost@dfci.harvard.edu
- Recruiting
Case Comprehensive Cancer Center, Case Western Medical Reserve
Cleveland, Ohio, 44106
Barbara Heaton, 216-844-7314, Barbara.Heaton@UHhospitals.org
Wendy Brock, RN, 216-844-3853, wendy.Brock@UHhospitals.org
- Recruiting
Yale University
New Haven, Connecticut, 06520
Scott Merenda, BSN, 203-785-7019, scott.merenda@yale.edu
James Farrell, MD
- Recruiting
NYU Langone Medical Center
New York, New York, 10016
Emil Agarunov, emil.agarunov@nyulangone.org
Tamas Gonda, MD
- Recruiting
Columbia University Medical Center
New York, New York, 10032
Katharine Godfrey, kb3217@cumc.columbia.edu
Fay Kastrinos, MD
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Daniel Clay, 215-360-0905, Daniel.Clay@Pennmedicine.upenn.edu
Sara Karley, sara.karley@pennmedicine.upenn.edu
- Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Christine Decapite, decapitec@upmc.edu
Sara Booz, boozs@upmc.edu
About this study
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.
Read the 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.
- Conditions
- Pancreas Cancer, Peutz-Jeghers Syndrome (PJS), Gene Mutation, Germline Mutation Carrier, Lynch Syndrome
- Being tested
- Secretin, MRI, Tumor marker gene test with CA19-9
- 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)
- Medical subject headings
- Pancreatic Neoplasms, Peutz-Jeghers Syndrome, Colorectal Neoplasms, Hereditary Nonpolyposis, Breast Neoplasms, Dysplastic Nevus Syndrome, Hereditary pancreatitis, Hereditary Sensory and Autonomic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SecretinDrug
Also called ChiRhoStim
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.
MRIDiagnostic test
Also called MRCP
MRI abdomen with contrast (MRCP) will be clinically indicated for abnormal novel CA-19-9 lab results.
Tumor marker gene test with CA19-9Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Familial pancreas cancer relatives | Active comparator | 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 Receives: Drug: Secretin; Diagnostic Test: MRI; Other: Tumor marker gene test with CA19-9 |
| Group 1 germline mutation carrier | Active comparator | 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. Receives: Drug: Secretin; Diagnostic Test: MRI; Other: Tumor marker gene test with CA19-9 |
| Group 2 germline mutation carrier | Active comparator | High Risk Group 4 (Group 2 germline mutation carriers with an associated with an estimated lifetime risk of pancreatic cancer of ~5%):
1. > 50 years old or 10 years younger than the age of the youngest relative with pancreatic cancer, and
2. 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. Receives: Drug: Secretin; Diagnostic Test: MRI; Other: Tumor marker gene test with CA19-9 |
| Hereditary pancreatitis | Active comparator | 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. Receives: Drug: Secretin; Diagnostic Test: MRI; Other: Tumor marker gene test with CA19-9 |
| Peutz-Jeghers Syndrome | Active comparator | 1. At least 30 years old, and
2. 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,
3. known STK11 gene mutation carrier Receives: Drug: Secretin; Diagnostic Test: MRI; Other: Tumor marker gene test with CA19-9 |
| Negative control | Active comparator | 1. 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
2. have no clinical or radiologic suspicion of pancreatic disease (chronic pancreatitis or pancreatic cancer) Receives: Drug: Secretin |
| Chronic Pancreatitis | Active comparator | 1. 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,
2. have no clinical or radiologic suspicion of pancreatic cancer Receives: Drug: Secretin |
| Pancreas cancer | Active comparator | 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) Receives: Drug: Secretin |
| Pancreas cyst, IPMN evaluation | Active comparator | 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). Receives: Drug: Secretin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 years
Secondary outcomes (1)
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.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2013 (estimated)
- Study start6 Jan 2014
- Primary completionDec 2028 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pancreas CancerStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Evaluation of the effect of diagnostic tests for pancreatic cancer
- Masking
- None (open label)
- Enrolment
- 9,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institutes of Health (NIH), American Association for Cancer Research
- Responsible party
- Sponsor
- Investigators
- Michael Goggins, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02000089
- Sponsor's protocol ID
- NA_00087754
- Other IDs
- 1U01CA210170-01, R01CA176828
- Acronym
- CAPS5
- Status last verified
- Oct 2026
- First submitted
- 26 Nov 2013
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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 34149034Kohi 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 33161160Abe 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 31676359Canto 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 31197699
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cancer of the Pancreas Screening-5 CAPS5)Study
- ClinicalTrials.gov ID
- NCT02000089
- Acronym / sponsor ID
- CAPS5 / NA_00087754
- Conditions
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 9,000 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institutes of Health (NIH), American Association for Cancer Research
- Study start
- 6 Jan 2014 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 3 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 9
- Model description
- Evaluation of the effect of diagnostic tests for pancreatic cancer
| Arm | Type | Receives |
|---|---|---|
| Familial pancreas cancer relatives | Active comparator | Drug: Secretin, Diagnostic Test: MRI, Other: Tumor marker gene test with CA19-9High 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 |
| Group 1 germline mutation carrier | Active comparator | Drug: Secretin, Diagnostic Test: MRI, Other: Tumor marker gene test with CA19-9High 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. |
| Group 2 germline mutation carrier | Active comparator | Drug: Secretin, Diagnostic Test: MRI, Other: Tumor marker gene test with CA19-9High Risk Group 4 (Group 2 germline mutation carriers with an associated with an estimated lifetime risk of pancreatic cancer of ~5%): 1. > 50 years old or 10 years younger than the age of the youngest relative with pancreatic cancer, and 2. 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. |
| Hereditary pancreatitis | Active comparator | Drug: Secretin, Diagnostic Test: MRI, Other: Tumor marker gene test with CA19-9High 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. |
| Peutz-Jeghers Syndrome | Active comparator | Drug: Secretin, Diagnostic Test: MRI, Other: Tumor marker gene test with CA19-91. At least 30 years old, and 2. 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, 3. known STK11 gene mutation carrier |
| Negative control | Active comparator | Drug: Secretin1. 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 2. have no clinical or radiologic suspicion of pancreatic disease (chronic pancreatitis or pancreatic cancer) |
| Chronic Pancreatitis | Active comparator | Drug: Secretin1. 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, 2. have no clinical or radiologic suspicion of pancreatic cancer |
| Pancreas cancer | Active comparator | Drug: Secretina. are undergoing EUS and/or ERCP for evaluation and/or treatment of suspected or proven pancreatic ductal adenocarcinoma (based on clinical and radiologic evidence) |
| Pancreas cyst, IPMN evaluation | Active comparator | Drug: Secretinare 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SecretinAlso: ChiRhoStiminject Secretin to stimulate pancreatic digestive fluid, which is collected in duodenum near ampulla via endoscope suction port. This fluid will be assessed for biomarkers. | Drug | Chronic Pancreatitis, Familial pancreas cancer relatives, Group 1 germline mutation carrier, Group 2 germline mutation carrier, Hereditary pancreatitis, Negative control, Pancreas cancer, Pancreas cyst, IPMN evaluation, Peutz-Jeghers Syndrome |
| MRIAlso: MRCPMRI abdomen with contrast (MRCP) will be clinically indicated for abnormal novel CA-19-9 lab results. | Diagnostic test | Familial pancreas cancer relatives, Group 1 germline mutation carrier, Group 2 germline mutation carrier, Hereditary pancreatitis, Peutz-Jeghers Syndrome |
| Tumor marker gene test with CA19-9A 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. | Other | Familial pancreas cancer relatives, Group 1 germline mutation carrier, Group 2 germline mutation carrier, Hereditary pancreatitis, Peutz-Jeghers Syndrome |
Primary outcome
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.
1 secondary outcome
Compare pancreas juice with pancreas cyst fluid
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Derived from this study: PubMed 34149034Kumar 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.
- Derived from this study: PubMed 33161160Kohi 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.
- Derived from this study: PubMed 31676359Abe 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.
- Derived from this study: PubMed 31197699Canto 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hilary Cosby, RN contact
Michael Goggins, MD principal investigator
Johns Hopkins University
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Secretin, MRI and Tumor marker gene test with CA19-9 in people with Pancreas Cancer and Peutz-Jeghers Syndrome (PJS), run by Johns Hopkins University at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hilary Cosby, RN (hcosby1@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate pancreatic juice for early cancer markers. (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02000089, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.