Point of Care Test to Diagnosed Colorectal Cancer and Polyps in Low Middle Income Countries

• Register: ClinicalTrials.gov
• Last refreshed on: 15 April 2024
• Main ID: NCT03173729
• Date of registration: 23/05/2017
• Prospective Registration: No
• Primary sponsor: Obafemi Awolowo University Teaching Hospital
• Public title: Point of Care Test to Diagnosed Colorectal Cancer and Polyps in Low Middle Income Countries
• Scientific title: Point of Care, Real-time Urine Metabolomics Test to Diagnose Colorectal Cancers and Polyps in Low and Middle Income Countries
• Date of first enrolment: February 11, 2017
• Target sample size: 926
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT03173729
• Study type: Observational

Countries of recruitment

Nigeria

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Colorectal Cancer

Intervention(s)

Diagnostic Test: Biosensor Point of Care Device

Primary Outcome(s)

Sensitivity and specificity of a point of care device to diagnose colorectal cancer and polyps [Time Frame: 5 years]

Secondary Outcome(s)

Number of patients that are willing to consider continued colorectal cancer surveillance with a urine point of care test. [Time Frame: 3 years]

Cost per patient of point of care urine test for diagnosing patients with colorectal cancer and polyps. [Time Frame: 3 years]

Secondary ID(s)

ERC/2017/02/11

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Memorial Sloan Kettering Cancer Center