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The Cancer of the Pancreas Screening-5 CAPS5)Study

Study acronym: CAPS5
StatusRecruiting
PhasePhase 3
Started2014-01-06
View on ClinicalTrials.gov ↗

Amendment history

2025-10-08
Study Status v38
Primary completion date2025-10→2028-12
Completion date2025-12→2029-06
2025-06-05
Study Status, Sponsor/Collaborators, Contacts/Locations v37
Study sites8→9
Collaborators2 to 3 entries
American Association for Cancer Research
2025-03-10
Study Status v36
Re-verified, no change to tracked fields
2024-11-19
Study Status, Contacts/Locations v35
Study sitescontacts updated at 1 of 8 sites
2024-10-17
Study Status, Sponsor/Collaborators, Oversight, Study Design, Eligibility, Contacts/Locations v34
Primary completion date2024-10→2025-10
Enrollment target7000→9000
Eligibility criteria+92 characters
[...] ly tree or Confirmed germline mutation carrier (BRCA2, FAMMM (CDKN2A/p16), PALB2, BRCA1, ATM, HNPCC, PRSS1/2Lynch Syndrome (hMLH1, orhMSH2, CTRCPMS2, hMSH6, EpCAM) PRSS1, PRSS2, R122H, N291l, SPINK1, CFTR Endoscopic evaluation of pancreas scheduled Exclusion Crite [...]
Study sitescontacts updated at 3 of 8 sites
Collaborators3 to 2 entries
ChiRhoClin, Inc.
Show 33 earlier versions
2024-03-14
Study Status v33
Re-verified, no change to tracked fields
2023-12-18
Study Identification, Study Status, Sponsor/Collaborators, Contacts/Locations v32
Study sitescontacts updated at 1 of 8 sites
Collaborators2 to 3 entries
National Institutes of Health (NIH)
2023-11-16
2 amendments v30-v31
2 re-verifications since 2023-05-15, no change to tracked fields
2022-12-12
Study Status, Contacts/Locations v29
Study sitescontacts updated at 1 of 8 sites
2022-08-16
Study Status, Conditions, Arms and Interventions, Outcome Measures v28
InterventionsMRI (Diagnostic Test), Secretin (Drug)→MRI (Diagnostic Test), Secretin (Drug), Tumor marker gene test with CA19-9 (Other)
2022-07-01
Study Status, Contacts/Locations v27
Study sitescontacts updated at 2 of 8 sites
2022-05-11
Study Status, Study Design, Arms and Interventions, Contacts/Locations v26
Enrollment target3000→7000
InterventionsHuman synthetic secretin (Drug)→MRI (Diagnostic Test), Secretin (Drug)
Study sitescontacts updated at 6 of 8 sites
2021-07-15
Study Status v25
Start date2014-01→2014-01-06
2021-07-09
Study Status, Study Design, Arms and Interventions, Eligibility v24
PhaseNot specified→Phase 3
2021-06-04
Study Status, Contacts/Locations v23
Study sitescontacts updated at 2 of 8 sites
2020-11-23
Study Status, Contacts/Locations v22
Study sitescontacts updated at 1 of 8 sites
2020-06-18
Study Status, Arms and Interventions v21
Re-verified, no change to tracked fields
2020-01-02
Study Status, Study Design, Arms and Interventions, Contacts/Locations v20
Study sitescontacts updated at 3 of 8 sites
2019-09-13
Study Status, Outcome Measures v19
Primary completion date2021-10→2024-10
Completion date2023-12→2025-12
Secondary endpointsdetails revised at 1 of 1 entry
2019-03-01
Study Identification, Study Status, Sponsor/Collaborators v18
Collaborators1 to 2 entries
National Cancer Institute (NCI)
2019-02-14
Study Status, Contacts/Locations v17
Study sitescontacts updated at 1 of 8 sites
2019-02-08
Study Status, Contacts/Locations v16
Study sitescontacts updated at 2 of 8 sites
2019-01-30
Study Status, Study Design, Contacts/Locations v15
Enrollment target2500→3000
Study sitesdetails revised at 4 of 8 sites
2018-08-16
Study Status v14
Re-verified, no change to tracked fields
2017-12-05
Study Status, Contacts/Locations v13
Study sitescontacts updated at 3 of 8 sites
2017-03-13
Study Status, Conditions, Arms and Interventions, Contacts/Locations v12
Study sitescontacts updated at 1 of 8 sites
2017-02-14
Study Status, Sponsor/Collaborators, Oversight, Conditions, Contacts/Locations, IPDSharing v11
Study sitescontacts updated at 1 of 8 sites
2016-09-07
Study Status, Contacts/Locations v10
Study sitescontacts updated at 3 of 8 sites
2016-02-22
Study Status, Arms and Interventions v9
Re-verified, no change to tracked fields
2015-09-21
Study Status, Contacts/Locations v8
Study sitesdetails revised at 1 of 8 sites
2015-07-17
Study Status v7
Re-verified, no change to tracked fields
2015-05-22
Study Status, Contacts/Locations v6
Study sitescontacts updated at 1 of 8 sites
2015-04-03
Study Status, Study Description, Contacts/Locations v5
Study description+234 characters
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 sitesdetails revised at 5 of 8 sites
2014-09-10
Study Status, Contacts/Locations v4
Study sitesdetails revised at 2 of 8 sites
2014-05-28
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Study sitesdetails revised at 8 of 8 sites
2014-01-08
Study Status, Contacts/Locations v2
Start date2013-12→2014-01
Study sites8 entries, revised
Case Comprehensive Cancer Center, Case Western Medical ResearveReserve
2013-12-19
Study Status, Contacts/Locations v1
Study sites7→8
2013-11-26
Original filing
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.
Trial Details
NCT Number NCT02000089
Lead Sponsor Johns Hopkins University
Collaborators: National Cancer Institute (NCI), National Institutes of Health (NIH), American Association for Cancer Research
Conditions Pancreas Cancer, Peutz-Jeghers Syndrome (PJS), Gene Mutation, Germline Mutation Carrier, Lynch Syndrome
Enrollment 9,000 participants
Start Date 2014-01-06
Primary Completion 2028-12 (estimated)
Study Completion 2029-06 (estimated)
Updated on ClinicalTrials.gov 2025-10-09