Collecting Blood and Stool Samples to Detect Colorectal Cancer or Advanced Neoplasia in Lynch Syn… (NCT05410977) | Clinical Trial Compass
RecruitingNot Applicable
Collecting Blood and Stool Samples to Detect Colorectal Cancer or Advanced Neoplasia in Lynch Syndrome Patients
United States750 participantsStarted 2022-03-30
Plain-language summary
This study collects blood and stool samples from patients with suspected or diagnosed Lynch syndrome to evaluate a deoxyribonucleic acid (DNA) screening technique for the detection of colorectal cancer in Lynch syndrome patients.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients at least 18 years of age
* Individuals diagnosed with Lynch syndrome (mutation in MLH1, MSH2, MSH6, PMS2, EPCAM) or colorectal cancer (CRC) with suspected Lynch syndrome or individuals diagnosed with early onset CRC (\<55 years old)
* Colonoscopy/flexible sigmoidoscopy (flex sig) scheduled +/- 90 days from sample collection
* Patient has agreed to participate and has signed the study consent form
Exclusion Criteria:
* Patient has known cancer (stage I-IV) within 5 years prior to current sample collection (not including basal cell or squamous cell skin cancers; if patient has not been seen or if information is not available, the patient is eligible)
* Patient has received chemotherapy class drugs for the treatment of cancer in the 5 years prior to current sample collection
* Patient has had any abdominal radiation therapy prior to current sample collection
* Patient had therapy to the target (non-hyperplastic) lesion with intent to completely remove or debulk the lesion prior to sample collection \[examples include snare polypectomy, endoscopic mucosal resection (EMR), endoscopic submucosal dissection (ESD), surgical resection, trans anal excision\]
* Patient has prior diagnosis of non-lynch hereditary colon cancer syndrome \[familial adenomatous polyposis (FAP), MUTYH-associated polyposis (MAP), Peutz-Jeghers syndrome (PJS), juvenile polyposis syndrome (JPS), PTEN, POL\]
* ADDITIONAL STOOL EXCLUSIONS:
* Bowel prep \<7 days prior to stool coll…
What they're measuring
1
Sensitivity of multitarget stool deoxyribonucleic acid (mt-sDNA) 2.0 test to detect colorectal neoplasia
Timeframe: Up to 4 years
2
Specificity of mt-sDNA 2.0 test to detect colorectal dysplasia