Treatment for Lynch Syndrome

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Case Comprehensive Cancer Center, Case Western Medical Reserve, Cleveland, OH
Lynch Syndrome+8 More
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This study is evaluating whether there are differences in the quality of the study at each site.

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Eligible Conditions

  • Lynch Syndrome
  • Malignant Neoplasm of Pancreas
  • Peutz-Jeghers Syndrome (PJS)
  • Gene Mutations
  • Germline Mutation Carrier

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome, 1 secondary outcome, and 2 other outcomes in patients with Lynch Syndrome. Measurement will happen over the course of 5 years.

10 years
Compare pancreas juice with pancreas cyst fluid
Evaluate pancreatic juice for early cancer markers.
Time disease progression and prevalence
5 years
Diagnostic performance of a tumor marker gene test for CA19-9 interpretation

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

9 Treatment Groups

Peutz-Jeghers Syndrome
1 of 9
Hereditary pancreatitis
1 of 9
Familial pancreas cancer relatives
1 of 9
Group 2 germline mutation carrier
1 of 9
Negative control
1 of 9
Chronic Pancreatitis
1 of 9
Pancreas cancer
1 of 9
Pancreas cyst, IPMN evaluation
1 of 9
Group 1 germline mutation carrier
1 of 9
Active Control

This trial requires 7000 total participants across 9 different treatment groups

This trial involves 9 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

Peutz-Jeghers SyndromeAt 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
Hereditary pancreatitisHigh 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.
Familial pancreas cancer relativesHigh 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 2 germline mutation carrierHigh 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.
Negative controlare 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)
Chronic Pancreatitisare 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
Pancreas cancera. are undergoing EUS and/or ERCP for evaluation and/or treatment of suspected or proven pancreatic ductal adenocarcinoma (based on clinical and radiologic evidence)
Pancreas cyst, IPMN evaluationare 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 1 germline mutation carrierHigh 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.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 10 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 10 years for reporting.

Closest Location

Case Comprehensive Cancer Center, Case Western Medical Reserve - Cleveland, OH

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 2 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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
Endoscopic evaluation of pancreas scheduled

Patient Q&A Section

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Are there any geographic restrictions to consider when applying for this trial?

Patients from any state can participate in this trial, so long as they are able to attend all treatment sessions.

Will my insurance cover participating in this trial?

In order to understand how insurance coverage works for this trial, you will need to contact the study coordinator.

See if you qualify for this trial
Get access to this novel treatment for Lynch Syndrome by sharing your contact details with the study coordinator.