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
- 暂停
- 发起方
- 入组人数
- 645
- 试验地点
- 2
- 主要终点
- Accuracy of Urine PolypDx device in detecting colorectal cancer
研究概览
简要总结
Study description: the study is a clinical trial aimed at assessing the validity of a point-of-care tool developed for colorectal cancer screening using urine metabolites.
Objectives:
Primary Objective:
In the pilot phase, investigators will field test the POC device in Nigeria on 75 patients who are high-risk for CRC and then validate the urine metabolite signature using a large cohort of 645 patients at high risk for CRC and polyps. This will allow us to determine the sensitivity and specificity of this device and these signatures for CRC and polyps.
Endpoints: the endpoint will be the calculation of the validity (sensitivity and specificity) of the tool. Positive and negative predictive values will also be calculated.
Study population:
Patients > 40 years of age with LGI bleeding for more than one-week OR
- Patients who are high risk due to a family history of CRC (first-degree relative)
- 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)
- Patients with a diagnosis of stage I-III CRC who have no evidence of disease Both males and females will be involved in the study
I. The study will evaluate the validity and acceptability of the POC biosensor device in Nigeria.
Description of sites/facilities enrolling participants: the study will be conducted at Obafemi Awolowo University Teaching Hospitals Complex (OAUTHC) which hosts the head office of African Research Group for Oncology (ARGO). The study will also run concurrently at other ARGO collaborating sites. All the ARGO collaborating sites are tertiary health care facilities with experienced personnel to oversee the study. The pilot study will, however, take place in OAUTHC alone.
Study duration:
The accrual time for the validation study is 2.5 years. Participant Duration: the study will require initial one-time contact. Those that are positive during the screening with the POC biosensor device will be booked for colonoscopy. Hence, for participants with positive results to complete the study may require 2 weeks on average.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
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 > 40 years of age with LGI bleeding for more than one week OR
- •Patients who are high risk due to a family history of CRC (first-degree relative)
- •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)
- •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 that the anesthesiologist or surgeon determines is a contraindication for colonoscopy in their facility.
- •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
Accuracy of Urine PolypDx device in detecting colorectal cancer
时间窗: One month
Results from the urine assay will be compared with the histology report of the tissue taken during colonoscopy, the gold standard for colorectal cancer diagnosis. Sensitivity, specificity, positive predictive value, and negative predictive values will be calculated
次要结局
- Positive Predictive Value Urine PolypDx device in detecting colorectal cancer (CRC)(One month)
- Specificity Urine PolypDx device in detecting colorectal cancer (CRC)(One month)
- Sensitivity Urine PolypDx device in detecting colorectal cancer (CRC)(One month)
- Negative Predictive Value Urine PolypDx device in detecting colorectal cancer (CRC)(One month)
研究者
Olusegun Alatise
Professor/Consultant Surgeon
Obafemi Awolowo University Teaching Hospital