Point of Care, Real-time Urine Metabolomics Test to Diagnose Colorectal Cancers and Polyps in Low and Middle Income Countries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 926
- 试验地点
- 5
- 主要终点
- Sensitivity and specificity of a point of care device to diagnose colorectal cancer and polyps
研究概览
简要总结
This is a-two phase study. Phase 1 will adapt a 3-metabolite biosensor that identifies patients with colorectal cancer (CRC) and precancerous polyps to Nigerian patients. Phase 2 will pilot test and evaluate the point-of-care (POC) biosensor device in Nigeria.
详细描述
In Phase 1, urine will be collected from 450 Nigerian patients (150 with CRC, 150 with polyps, and 150 patients with no colon premalignant or malignant pathology. These samples will be used to refine a handheld biosensor. This handheld biosensor is intended to be a cost-effective POC diagnostic test highly sensitive for CRC in Nigerian patients.
In Phase 2, the biosensor device will be piloted in Nigeria with 75 patients that are high-risk for CRC.. After the pilot, POC test in real-time analysis on urine from 645 patients who are in one of three groups: 1.> 40 years of age with rectal bleeding; 2.a family history of CRC; 3. have a diagnosis of CRC. All patients will receive a colonoscopy. Beliefs and barriers related to urine testing for CRC will be investigated. Study will be completed within 5 years.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients > 40 years of age with LGI bleeding OR
- •Patients who are high risk due to family history of CRC
- •o Must be at most 10 years younger than when relative presented with CRC (for example, a patient with a relative diagnosed at age 40 with CRC will be eligible after age 30) OR
- •Patients with a diagnosis of stage I-III CRC who have no evidence of disease
排除标准
- •Patients who are unable to provide written informed consent;
- •Previous diagnosis, treatment, or surgery for any cancer other than CRC
- •Age younger than 40 years with no family history of CRC
- •Any significant medical comorbidities
- •Inability to provide a urine sample no fewer than 3 days before colonoscopy
- •Inability to fully complete the patient satisfaction survey tool
- •Diagnosis of or suspected inflammatory bowel disease.
结局指标
主要结局
Sensitivity and specificity of a point of care device to diagnose colorectal cancer and polyps
时间窗: 5 years
We have designed a urine-based point of care diagnostic test to risk-stratify patients at high-risk for colorectal cancer. that will have 50% specificity and 80% sensitivity among Nigerian targeted population.
次要结局
- Cost per patient of point of care urine test for diagnosing patients with colorectal cancer and polyps.(3 years)
- Number of patients that are willing to consider continued colorectal cancer surveillance with a urine point of care test.(3 years)
研究者
Olusegun Alatise
Dr
Obafemi Awolowo University Teaching Hospital