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CAPS5 Trial Summary
This trial will be monitored by Johns Hopkins and Sub Investigators at each site.
- Pancreatic Cancer
- Lynch Syndrome
- Peutz-Jeghers Syndrome
CAPS5 Trial Eligibility Criteria
Inclusion CriteriaYou will be eligible if you check “Yes” for the criteria below
CAPS5 Trial Timeline
Study ObjectivesOutcome measures can provide a clearer picture of what you can expect from a treatment.
Awards & Highlights
CAPS5 Trial Design
Find a Location
Who is running the clinical trial?
- You have a condition called Peutz-Jeghers Syndrome.You have a blockage or narrowing in your upper digestive system that prevents the doctor from using a special tool called an echoendoscope.You have other medical conditions or bleeding disorders that make it unsafe to perform an endoscopy.Many of your close family members on one side of the family have had pancreatic cancer.
- Group 1: Group 2 germline mutation carrier
- Group 2: Hereditary pancreatitis
- Group 3: Peutz-Jeghers Syndrome
- Group 4: Familial pancreas cancer relatives
- Group 5: Negative control
- Group 6: Chronic Pancreatitis
- Group 7: Pancreas cancer
- Group 8: Pancreas cyst, IPMN evaluation
- Group 9: Group 1 germline mutation carrier
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are they enrolling new participants at this time?
"The clinical trial is currently ongoing, as shown by the posting date and most recent update on clinicaltrials.gov. Originally, the study was looking for 7000 participants from 8 different sites."
Are there previous examples of research done on people with Group 2 germline mutations?
"Group 2 germline mutation carriers were first studied in 2014 at Case Comprehensive Cancer Center. As of now, there have been a total of 175 completed clinical trials, with 3 live clinical trials. Many of these studies are based in Boston, Massachusettse Cancer Center. As of now, there have been a total of 175 completed clinical trials, with 3 live clinical trials. Many of these studies are based in Boston, Massachusetts."
Has the FDA cleared Group 2 germline mutation carriers for use?
"Group 2 germline mutation carriers have been studied in Phase 3 trials, so there is some data suggesting efficacy as well as multiple rounds of data affirming safety. Consequently, our team rates it as a 3."
What do we use Group 2 germline mutation carriers to help patients with?
"Group 2 germline mutation carriers can be used to not only treat lactation, but also gastrinoma, process of secretion, and pancreatic exocrine dysfunction."
How many test subjects are signed up for this research?
"In order to carry out this research, 7000 individuals that align with the pre-determined inclusion criteria are necessary. The sponsor, ChiRhoClin, Inc., will administer the trial from multiple locations, including Dana Farber Cancer Center, Harvard University in Boston, Massachusetts and University of Pittsburgh in Pittsburgh, Pennsylvaniaber Cancer Center, Harvard University in Boston, Massachusetts and University of Pittsburgh in Pittsburgh, Pennsylvania."
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