Evaluating the Cologuard Test for Use in Lynch Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Evaluate the feasibility of the Cologuard test for Lynch Syndrome
研究概览
简要总结
This study is aiming to enroll 90 patients with genetically confirmed Lynch Syndrome (LS) from Geisinger's High Risk Colorectal Cancer Clinic (HRC). Upon enrollment in the study, a Cologuard test will be ordered and the results will be blinded until data analysis. Patients enrolled in the study will also undergo a colonoscopy as part of their routine HRC visit.
详细描述
The primary aim is to perform a pilot study to gain information toward the implementation of a larger prospective study that will compare the performance of Cologuard with the gold-standard colonoscopy in identifying advanced adenomas and colorectal cancers in LS. Data regarding rate of consent, and adherence to the protocol will be recorded. Since patients with known genetic predisposition to cancers tend to view screening tests more positively than the general population, a second aim of the study is to evaluate patient satisfaction with bowel preparation, colonoscopies, and Cologuard testing. Up to 90 individuals with genetically confirmed LS will be recruited via Geisinger's HRC to complete a goal of 90 Cologuard studies. Upon enrollment, Cologuard will be ordered by the study team at no cost to the subject and will be completed according to the standard instructions for use. Results will be securely obtained and blinded until the time of data analysis. Subjects will undergo colonoscopy as part of their routine HRC visit. Results from the colonoscopy (and biopsy as indicated) will be retrieved from the Electronic Health Record (EHR) and documented in a research-associated spreadsheet. If repeat colonoscopy is clinically indicated, repeat Cologuard may be completed if the subject meets inclusion criteria.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients age 18-89
- •Diagnosis of genetically confirmed LS
- •Scheduled for standard of care colonoscopy within 60 days of enrollment
排除标准
- •Diagnosis of other inherited genetic disorders that increase risk for Colorectal Cancer (CRC) (Familial Adenomatous Polyposis (FAP), Cowden's syndrome, Turcot syndrome, Gardner syndrome, and Peutz-Jeghers syndrome)
- •Diagnosis of other inherited Inflammatory bowel disease (i.e. Crohn disease, ulcerative colitis)
- •Others with elevated risk of CRC outside of the inclusion criteria (i.e. ≥2 first-degree relatives who have been diagnosed with CRC without a defined inherited genetic disorder, Hereditary Non-Polyposis Colon Cancer (HNPCC) without genetic confirmation of LS)
- •Participation in any interventional clinical study within the previous 30 days
- •Personal history of CRC not in full remission (5 consecutive cancer-free years)
- •Current active treatment with chemotherapy
- •Treatment with chemotherapy within 12 months prior to consent date
结局指标
主要结局
Evaluate the feasibility of the Cologuard test for Lynch Syndrome
时间窗: 3 months
To evaluate the feasibility of Cologuard in a high-risk population, a summary report of the enrollment/consent rate and adherence to the protocol will be provided. Additional analyses comparing the results (given as positive/negative) Cologuard with the gold standard of colonoscopy will be performed using diagnostic tests including sensitivity, specificity, positive predictive value and negative predictive value.
次要结局
- Evaluate bowel preparation tolerability(3 months)
- Evaluate anxiety symptoms surrounding routine colonoscopy(3 months)
- Evaluate patient satisfaction with Cologuard(3 months)
- Evaluate health-related quality of life in Lynch Syndrome(3 months)
- Evaluate depressive symptoms(3 months)
研究者
Rajiv Panikkar
Sponsor - Investigator
Geisinger Clinic