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FITting Non-invasive Tests in Lynch Syndrome Surveillance

FITting Non-invasive Testing Into Lynch Syndrome Colorectal Cancer Surveillance: a Multi-center, Prospective Study

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
20 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how accurate FIT, a stool test for blood, is compared with colonoscopy, a camera exam of the colon. It is for people with Lynch syndrome, an inherited condition that raises cancer risk, who are having regular colon checks.

The purpose of this clinical study is to evaluate the accuracy of the fecal immunochemical test (FIT) in comparison to colonoscopy in patients with Lynch Syndrome (LS) who are undergoing colonoscopy surveillance.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have Lynch syndrome confirmed by a harmful change in the MLH1, MSH2, MSH6, PMS2, or EPCAM gene.
  • Be 20–80 years old if the gene change is in MLH1, MSH2, or EPCAM.
  • Be 30–80 years old if the gene change is in PMS2 or MSH6.
  • Have an upcoming routine colonoscopy that follows Lynch syndrome screening guidelines.
  • If you had colon surgery, have at least 20 centimeters of colon left.
  • The list includes people with advanced abnormal growths or cancer that have not been removed by a scope or surgery.
  • Be willing to sign a form agreeing to join, collect stool samples, and fill out surveys.

Who can't join

  • Have not had genetic testing to confirm Lynch syndrome, even if you have a family history or qualify for testing.
  • Have had all or most of your colon removed.
  • Are newly diagnosed with Lynch syndrome, under 20, and have a harmful change in any of the listed genes.
  • Are newly diagnosed with Lynch syndrome, under 30, and have a harmful change in MSH6 or PMS2.
  • Are pregnant.
  • Have inflammatory bowel disease, which causes swelling in the bowel, or active cancer. The listing also includes some people with cancer above, so ask the study team to clarify.
  • Are unwilling or unable to sign a form agreeing to join.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Have a diagnosis of LS with a confirmed pathogenic variant in MLH1, MSH2, MSH6, PMS2 or EPCAM genes. * Aged 20 - 80 years (for those with pathogenic variants in MLH1, MSH2, and EPCAM) * Aged 30 - 80 years (for those with pathogenic variants in PMS2 or MSH6). * Have an upcoming standard of care (SOC) colonoscopy appointment in line with standard LS surveillance guidelines (NCCN). * Patients with previous colon surgery who still have 20cm or more of colon remaining * Patients who are diagnosed with advanced neoplasia (e.g., advanced adenomas or cancers) and have NOT had endoscopic or surgical resection * Willing to sign informed consent, collect stools samples and complete surveys Exclusion Criteria: * Individuals who have not proceeded with genetic testing and therefore are not known to have LS, despite family history and/or criteria for testing. * Individuals who have previously undergone a subtotal or total colectomy. * Newly diagnosed Lynch Syndrome patients \< 20 years old with a pathogenic variant in MLH1, MSH2 or EPCAM, MSH6 or PMS2. * Newly diagnosed Lynch Syndrome patients \< 30 years old with a pathogenic variant in MSH6 or PMS2. * Individuals who are pregnant. * Individuals with inflammatory bowel disease or active malignancy. * Individuals not willing or able to sign informed consent.

Study sites (3)

IL

MI

NY