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

Obafemi Awolowo University Teaching Hospital

Status: Completed

Conditions: Colorectal Cancer

Treatments: Diagnostic Test: Biosensor Point of Care Device

Study type: Observational

Funder types: Other

Identifiers

NCT03173729

ERC/2017/02/11

Details and patient eligibility

About

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.

Full 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.

Enrollment: 926 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

926 participants in 7 patient groups

Phase 1 Cohort 1

Description:

CRC (n = 150)

Phase 1 Cohort 2

Description:

Precancerous polyps (n = 150)

Phase 1 Cohort 3

Description:

Normal controls (n = 150)

Phase 2 Field Test

Description:

75 patients who are high risk for CRC as described in the eligibility

Treatment:

Diagnostic Test: Biosensor Point of Care Device

Phase 2 Validation Study Cohort 1

Description:

Family history of CRC (n = 330)

Treatment:

Diagnostic Test: Biosensor Point of Care Device

Phase 2 Validation Study Cohort 2

Description:

LGI bleeding (n = 240)

Treatment:

Diagnostic Test: Biosensor Point of Care Device

Phase 2 Validation Study Cohort 3

Description:

Patients with history of CRC (n = 75)

Treatment:

Diagnostic Test: Biosensor Point of Care Device