UPCC 17224 Detection of Colorectal Cancer or Advanced Neoplasia by Stool DNA in Lynch Syndrome: CORAL Study
Investigating a DNA Screening Method for Colorectal Cancer
Brief description of study
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.
Detailed description of study
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 colorectal cancer.
OUTLINEPatients 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.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Colorectal Carcinoma, Lynch Syndrome
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Age: 18 years or above
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Gender: All
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
This study investigates a DNA screening technique to detect colorectal cancer in patients with Lynch syndrome. The purpose of this study is to evaluate how well a specific DNA test, called the multitarget stool DNA (mt-sDNA) 2.0 test, works in identifying colorectal cancer in these patients.
Participants in this study will provide blood and stool samples. These samples are collected either up to 90 days before or between 7 and 90 days after a standard colonoscopy or flexible sigmoidoscopy. Researchers will also review the participants' medical records to gather more information.
- Who can participate: Adults aged 18 and older who have been diagnosed with Lynch syndrome or early onset colorectal cancer are eligible to participate. Participants must have a colonoscopy or flexible sigmoidoscopy scheduled within 90 days of sample collection and must consent to participate. Individuals with a recent cancer diagnosis, or those undergoing chemotherapy or radiation therapy, are excluded.
- Study details: Participants will provide blood and stool samples for analysis. The samples are collected around the time of their scheduled colonoscopy or flexible sigmoidoscopy. Medical records will also be reviewed as part of the study.
Study is selecting its participants from a population, or group of people, decided on by the researchers in advance.
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