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Pancreatic Cancer Screening for Pancreatic Cancer (CAPS5 Trial)
Phase 3
Recruiting
Led By Michael Goggins, MD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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, PALB2, BRCA1, HNPCC, PRSS1/2, or CTRC
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 years
Awards & highlights
CAPS5 Trial Summary
This trial will be monitored by Johns Hopkins and Sub Investigators at each site.
Who is the study for?
This trial is for individuals with a scheduled endoscopic evaluation of the pancreas, who either have Hereditary Pancreatitis, Peutz-Jeghers Syndrome, a strong family history of pancreatic cancer, or specific genetic mutations. It's not suitable for those with upper GI tract obstructions, inability to consent, conditions that make endoscopy risky, certain prior surgeries like gastrectomy or if pregnant.Check my eligibility
What is being tested?
The CAPS5 Study is testing the effectiveness of secretin and tumor marker gene tests (including CA19-9) alongside MRI in detecting pancreatic cancer in high-risk groups. The study will be monitored by Johns Hopkins' quality assurance group and sub-investigators at each site.See study design
What are the potential side effects?
While this trial focuses on screening methods rather than treatments that typically have side effects like drugs do, procedures involved may include discomfort from endoscopy and potential risks associated with MRIs such as reactions to contrast agents used.
CAPS5 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a genetic condition or a strong family history of 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
CAPS5 Trial Design
9Treatment groups
Active Control
Group I: 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 II: 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 III: 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 IV: 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 V: 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.
Group VI: 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 VII: 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 VIII: 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 IX: 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.
Find a Location
Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,263 Previous Clinical Trials
14,816,165 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,918,854 Total Patients Enrolled
ChiRhoClin, Inc.Industry Sponsor
9 Previous Clinical Trials
905 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My health severely limits my daily activities.I have a blockage in my upper digestive tract that prevents certain medical procedures.I have a genetic condition or a strong family history of pancreatic cancer.I am scheduled for a pancreas examination using an endoscope.I have health conditions that make endoscopy unsafe for me.I've had surgery on my stomach that affects certain medical imaging tests.
Research Study Groups:
This trial has the following groups:- Group 1: Pancreas cyst, IPMN evaluation
- Group 2: Chronic Pancreatitis
- Group 3: Negative control
- Group 4: Hereditary pancreatitis
- Group 5: Group 1 germline mutation carrier
- Group 6: Peutz-Jeghers Syndrome
- Group 7: Familial pancreas cancer relatives
- Group 8: Pancreas cancer
- Group 9: Group 2 germline mutation carrier
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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, 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, Pennsylvania."
Answered by AI
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