Clinical trial NCT03173729: Point of Care Test to Diagnosed Colorectal Cancer and Polyps in Low Middle Income Countries
Official title: Point of Care, Real-time Urine Metabolomics Test to Diagnose Colorectal Cancers and Polyps in Low and Middle Income Countries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Lead sponsor: Obafemi Awolowo University Teaching Hospital
Sponsor class: OTHER
Collaborators: name: Memorial Sloan Kettering Cancer Center
First posted: 2017-06-02
Enrollment: 926
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in Phase 1 has a pathologic diagnosis of colon cancer (either by colonoscopy or resection specimens), or colonoscopy demonstrating adenomatous polyps or no colon premalignant or malignant pathology.

Patients in Phase 2 are \> 40 years of age with LGI bleeding, or at high-risk due to family history, or with a history of CRC

Brief summary: 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.

Detailed description: 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.

Eligibility 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.

Primary outcomes:
measure: Sensitivity and specificity of a point of care device to diagnose colorectal cancer and polyps
timeFrame: 5 years
Secondary outcomes:
measure: Number of patients that are willing to consider continued colorectal cancer surveillance with a urine point of care test.
timeFrame: 3 years
measure: Cost per patient of point of care urine test for diagnosing patients with colorectal cancer and polyps.
timeFrame: 3 years
Other outcomes:
Locations:
city: Ilorin
country: Nigeria
facility: Endoscopy Unit, University of Ilorin Teaching Hospital
state: Kwara State
city: Owo
country: Nigeria
facility: Federal Medical Center
state: Ondo State
city: Ibadan
country: Nigeria
facility: Endoscopy Unit, University College Hospital
state: Osun State
city: Osogbo
country: Nigeria
facility: Ladoke Akintola University Teaching Hospital
state: Osun State
city: Ile Ife
country: Nigeria
facility: Endoscopy Unit, Obafemi Awolowo University Teaching Hospitals
state: Osun
Study officials:
References: