Collecting Blood And Stool Samples To Detect Colorectal Cancer Or Advanced Neoplasia In Lynch Syndrome Patients, CORAL Study

Overview

About this study

The purpose of this study is to to determine the sensitivity and specificity of a second-generation multi-target stool DNA test (mt-sDNA 2.0) (Cologuard 2.0®, Exact Sciences Corporation) for colorectal neoplasia (CRN) in subjects with Lynch syndrome.

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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 CRC (< 50 years old).
  • Colonoscopy scheduled +/- 90 days.

Exclusion Criteria: 

  • Individuals who have not agreed to participate and have not signed the study consent form.
  • 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 still 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 polypectomy, EMR, ESD, surgical resection, trans anal excision).

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 TPN.
  • Diagnosis of inflammatory bowel disease.

Eligibility last updated 9/28/21. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

John Kisiel, M.D.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Rosalie Himle

5072665755

lamere.rosalie@mayo.edu

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Niloy Jewel Samadder, M.D.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Shatika Price

4805744435

price.shatika@mayo.edu

Jacksonville, Fla.

Mayo Clinic principal investigator

Douglas Riegert-Johnson, M.D.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions