Collecting Blood and Stool Samples to Detect Colorectal Cancer or Advanced Neoplasia in Lynch Syndrome Patients

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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]

Trial population

Adults diagnosed with Lynch syndrome or suspected Lynch syndrome or early onset colorectal cancer.

Trial design

Design model

Case-only

Time perspective

Cross-sectional

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo collection of blood and stool samples

  • Electronic Health Record Review

    Other intervention

    Medical records reviewed

Treatment groups

950 Participants
are divided into 1 treatment group
Group A: Observational (biospecimen collection, record review)2 interventions

Trial outcomes

Primary outcomes

1

Sensitivity of multitarget stool deoxyribonucleic acid (mt-sDNA) 2.0 test to detect colorectal neoplasia

Results of the mt-sDNA 2.0 test will be correlated with pathology findings of patients undergoing colonoscopy to determine sensitivity of the mt-sDNA 2.0 test

Time frame
Up to 4 years
2

Specificity of mt-sDNA 2.0 test to detect colorectal dysplasia

Results of the mt-sDNA 2.0 test will be correlated with pathology findings of patients undergoing colonoscopy to determine specificity of the mt-sDNA 2.0 test

Time frame
Up to 4 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Exact Sciences Corporation

Collaborator