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

Официальное название

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

Обзор

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.

Подробное описание

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.

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.

Вмешательства

• Процедура Biospecimen Collection
  Undergo collection of blood and stool samples
• Другое Electronic Health Record Review
  Medical records reviewed

Первичные конечные точки

• Sensitivity of multitarget stool deoxyribonucleic acid (mt-sDNA) 2.0 test to detect colorectal neoplasia [Срок оценки: Up to 4 years]
• Specificity of mt-sDNA 2.0 test to detect colorectal dysplasia [Срок оценки: Up to 4 years]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

США · 9 центров

• Mayo Clinic in Arizona — Scottsdale
• University of California San Francisco — San Francisco
• University of Colorado Anschutz Medical Center — Aurora
• Mayo Clinic in Florida — Jacksonville
• Beth Israel Deaconess Medical Center — Boston
• Dana Farber Cancer Institute — Boston
• Mayo Clinic — Rochester
• University of Pennsylvania — Philadelphia
• … и ещё 1 центр

Идентификаторы

NCT: NCT05410977 · CORAL · 21-010010

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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