Colorectal CancerNCT06898996
FITting Non-invasive Tests in Lynch Syndrome Surveillance
A study testing Fecal immunochemical test in people with Colorectal Cancer, run by University of Chicago at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Fecal immunochemical test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 3 sitesUnited States
- Study dates
- 10 Jul 2025to 1 Jul 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Elena Stoffel, MD, 734-647-7558, estoffel@med.umich.edu
- Recruiting
The University of Chicago Medical Center
Chicago, Illinois, 60639
Sonia Kupfer, MD, 773-834-1438, skupfer@bsd.uchicago.edu
- Recruiting
Columbia University
New York, New York, 10032
Fay Kastrinos, MD, 212-305-1021, fk18@cumc.columbia.edu
About this study
Official title: FITting Non-invasive Testing Into Lynch Syndrome Colorectal Cancer Surveillance: a Multi-center, Prospective Study
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.
Read the detailed description
Lynch syndrome (LS), the most common inherited cause of colorectal cancer (CRC) affecting about 1.2 million Americans. Colonoscopy starting early in adulthood and repeated yearly or biennially is the only recommended surveillance strategy which translates into about 25-50 lifetime colonoscopies. This intensive colonoscopy surveillance is not ideal because CRC risk varies widely by LS gene and age, colonoscopies are invasive, costly, and not readily accessible to all patients, and adherence is suboptimal.
This clinical study will examine the performance of the fecal immunochemical test (FIT) in Lynch Syndrome (LS) patients undergoing colonoscopy surveillance. In addition to assessing the characteristics of the FIT test, such as specificity, sensitivity, and both negative and positive predictive values, the study will also explore LS patients' attitudes toward and acceptability of non-invasive testing methods. This comprehensive approach aims to provide insights into both the diagnostic effectiveness of FIT and the potential for improving patient adherence to screening protocols through less invasive options.
- Conditions
- Colorectal Cancer
- Being tested
- Fecal immunochemical test
- Keywords
- Lynch Syndrome, Colorectal Cancer
- Medical subject headings
- Colorectal Neoplasms, Colorectal Neoplasms, Hereditary Nonpolyposis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal immunochemical testOther
Detects blood in stool
| Study group | Role | What they receive |
|---|---|---|
| Non-invasive surveillance test | Experimental | Easily accessible, affordable and acceptable tests can be used to triage Lynch syndrome patients to colonoscopy Receives: Other: Fecal immunochemical test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative Measure of specificity
Measure specificity of Fecal immunochemical test (FIT) in Lynch Syndrome (LS) patients undergoing colonoscopy surveillance
Measured: baseline -12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study start10 Jul 2025
- Primary completion1 Mar 2029 (estimated)
- Study completion1 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sonia Kupfer, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06898996
- Sponsor's protocol ID
- IRB23-1133
- Other IDs
- R01CA287257-01
- Status last verified
- Oct 2026
- First submitted
- 20 Mar 2025
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No