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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Hereditary Pancreatitis
Confirmed germline mutation carrier (BRCA2, FAMMM, PALB2, BRCA1, HNPCC, PRSS1/2, or CTRC)
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up10 years
Awards & highlights
Pivotal Trial
No Placebo-Only Group
CAPS5 Trial Summary
This trial will be monitored by Johns Hopkins and Sub Investigators at each site.
Eligible Conditions
- Pancreatic Cancer
- Lynch Syndrome
- Peutz-Jeghers Syndrome
- Mutations
CAPS5 Trial Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You have a condition called Peutz-Jeghers Syndrome.
Select...
Many of your close family members on one side of the family have had pancreatic cancer.
CAPS5 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Evaluate pancreatic juice for early cancer markers.
Secondary outcome measures
Compare pancreas juice with pancreas cyst fluid
Other outcome measures
CA-19-9 Antigen
Time disease progression and prevalence
Awards & Highlights
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.
CAPS5 Trial Design
9Treatment groups
Active Control
Group I: Group 2 germline mutation carrierActive Control3 Interventions
High Risk Group 4 (Group 2 germline mutation carriers with an associated with an estimated lifetime risk of pancreatic cancer of ~5%):
> 50 years old or 10 years younger than the age of the youngest relative with pancreatic cancer, and
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.
Group II: Hereditary pancreatitisActive Control3 Interventions
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.
Group III: Peutz-Jeghers SyndromeActive Control3 Interventions
At least 30 years old, and
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,
known STK11 gene mutation carrier
Group IV: Familial pancreas cancer relativesActive Control3 Interventions
High Risk Group 2 (familial pancreatic cancer relatives):
> 55 years old or 10 years younger than the age of youngest relative with pancreatic cancer, and
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
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 V: Negative controlActive Control1 Intervention
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
have no clinical or radiologic suspicion of pancreatic disease (chronic pancreatitis or pancreatic cancer)
Group VI: Chronic PancreatitisActive Control1 Intervention
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,
have no clinical or radiologic suspicion of pancreatic cancer
Group VII: Pancreas cancerActive Control1 Intervention
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)
Group VIII: Pancreas cyst, IPMN evaluationActive Control1 Intervention
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).
Group IX: Group 1 germline mutation carrierActive Control3 Interventions
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.
Find a Location
Who is running the clinical trial?
ChiRhoClin, Inc.Industry Sponsor
9 Previous Clinical Trials
1,678 Total Patients Enrolled
Johns Hopkins UniversityLead Sponsor
2,192 Previous Clinical Trials
14,796,424 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,487 Previous Clinical Trials
41,259,732 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- 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
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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