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

Colorectal Carcinoma Clinical Trial

Official title:

Detection of Colorectal Cancer or Advanced Neoplasia by Stool DNA in Lynch Syndrome: CORAL Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05410977
• Other study ID #: 21-010010
• Secondary ID: NCI-2022-02032
• Status: Recruiting
• Start date: March 30, 2022
• Est. completion date: April 1, 2026

Study information

• Verified date: January 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

PRIMARY OBJECTIVE:

I. To determine the sensitivity and specificity of the multitarget stool DNA (mt-sDNA) 2.0 test, for colorectal neoplasia in patients with Lynch syndrome.

SECONDARY OBJECTIVE:

I. Develop a biorepository of samples (stool and blood) from patients with Lynch syndrome and early onset (< 50 years old) colorectal cancer.

OUTLINE:

Patients undergo collection of blood and stool samples no more than 90 days prior to or between 7-90 days after standard of care colonoscopy or flexible sigmoidoscopy. Patients' medical records are also reviewed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 750
• Est. completion date: April 1, 2026
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients at least 18 years of age

• Individuals diagnosed with Lynch syndrome (mutation in MLH1, MSH2, MSH6, PMS2, EPCAM) or suspected Lynch syndrome or individuals diagnosed with early onset colorectal cancer (CRC) (< 50 years old [yo])

• 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) 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 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

• Removal of more than 50% of colon or presence of ileostomy

• Enteral feeds or total parenteral nutrition (TPN)

• Diagnosis of inflammatory bowel disease

Related Conditions & MeSH terms

• Colorectal Carcinoma
• Colorectal Neoplasms
• Colorectal Neoplasms, Hereditary Nonpolyposis
• Lynch Syndrome
• Syndrome

Intervention

Procedure:
• Biospecimen Collection
Undergo collection of blood and stool samples

Other:
• Electronic Health Record Review
Medical records reviewed

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida
United States	Mayo Clinic	Rochester	Minnesota
United States	Mayo Clinic in Arizona	Scottsdale	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Exact Sciences Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity of multitarget stool deoxyribonucleic acid (mt-sDNA) 2.0 test to detect colorectal neoplasia		Up to 4 years
Primary	Specificity of mt-sDNA 2.0 test to detect colorectal dysplasia		Up to 4 years

External Links

•   Mayo Clinic Clinical Trials