Detection of Colorectal Cancer or Advanced Neoplasia by Stool DNA in Lynch Syndrome: CORAL Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 950
- 试验地点
- 19
- 主要终点
- Sensitivity of multitarget stool deoxyribonucleic acid (mt-sDNA) 2.0 test to detect colorectal neoplasia
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Observational (biospecimen collection, record review)
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.
干预措施: Biospecimen Collection (Procedure)
Observational (biospecimen collection, record review)
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.
干预措施: Electronic Health Record Review (Other)
结局指标
主要结局
Sensitivity of multitarget stool deoxyribonucleic acid (mt-sDNA) 2.0 test to detect colorectal neoplasia
时间窗: Up to 4 years
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
Specificity of mt-sDNA 2.0 test to detect colorectal dysplasia
时间窗: Up to 4 years
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
次要结局
未报告次要终点