Blood and Stool Samples to Detect Colorectal Cancer
Collecting Blood and Stool Samples to Detect Colorectal Cancer or Advanced Neoplasia in Lynch Syndrome Patients
Recruiting
Observational Study
Colorectal CarcinomaLynch Syndrome
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
950 (estimated)
Sponsor
Mayo Clinic · Other
Who this trial is looking for
This trial is looking for patients with Lynch syndrome or colorectal cancer. Participants will provide blood and stool samples to help test a new screening method for colorectal cancer.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I have been diagnosed with Lynch syndrome or colorectal cancer.
I have colonoscopy or flexible sigmoidoscopy scheduled within 90 days.
I have agreed to participate and signed the consent form.
You may not be able to join if
I have known cancer (stage I-IV) in the past 5 years.
I have received chemotherapy for cancer in the past 5 years.
I have had abdominal radiation therapy before providing samples.
I have had therapy aimed at completely removing or reducing a lesion.
I have a prior diagnosis of a non-lynch hereditary colon cancer syndrome.
I had bowel prep within 7 days before stool collection.
I had oral or rectal contrast in the 7 days before stool collection.
I have a diagnosis of inflammatory bowel disease.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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Eligibility Criteria
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 sigmoidoscop…
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 collection
* Oral or rectal contrast given within 7 days prior to stool collection
* Presence of ileostomy
* Enteral feeds or total parenteral nutrition (TPN)
* Diagnosis of inflammatory bowel disease
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