NCT02000089 The Cancer of the Pancreas Screening-5 CAPS5)Study
| NCT ID | NCT02000089 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Johns Hopkins University |
| Condition | Pancreas Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 9,000 participants |
| Start Date | 2014-01-06 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 9,000 participants in total. It began in 2014-01-06 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Hilary Cosby, RN
✉ hcosby1@jhmi.eduMichael Goggins, MD
PRINCIPAL INVESTIGATOR
Johns Hopkins University
Frequently Asked Questions
Who can join the NCT02000089 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pancreas Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT02000089 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 9,000 participants.
Is NCT02000089 currently recruiting?
Yes, NCT02000089 is actively recruiting participants. Contact the research team at hcosby1@jhmi.edu for enrollment information.
Where is the NCT02000089 trial being conducted?
This trial is being conducted at New Haven, United States, Baltimore, United States, Boston, United States, Ann Arbor, United States and 5 additional locations.
Who is sponsoring the NCT02000089 clinical trial?
NCT02000089 is sponsored by Johns Hopkins University. The principal investigator is Michael Goggins, MD at Johns Hopkins University. The trial plans to enroll 9,000 participants.
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