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

NCT03173729 | Completed

• 1 other identifier: ERC/2017/02/11
• Study Type: observational
• Target: 926
• Locations: 1 country
• Sites: 5

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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity of a point of care device to diagnose colorectal cancer and polyps

  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.

  5 years

Secondary Outcomes (2)

• Number of patients that are willing to consider continued colorectal cancer surveillance with a urine point of care test.

  3 years

• Cost per patient of point of care urine test for diagnosing patients with colorectal cancer and polyps.

  3 years

Study Arms (7)

Phase 1 Cohort 1

CRC (n = 150)

Phase 1 Cohort 2

Precancerous polyps (n = 150)

Phase 1 Cohort 3

Normal controls (n = 150)

Phase 2 Field Test

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

Diagnostic Test: Biosensor Point of Care Device

Phase 2 Validation Study Cohort 1

Family history of CRC (n = 330)

Diagnostic Test: Biosensor Point of Care Device

Phase 2 Validation Study Cohort 2

LGI bleeding (n = 240)

Diagnostic Test: Biosensor Point of Care Device

Phase 2 Validation Study Cohort 3

Patients with history of CRC (n = 75)

Diagnostic Test: Biosensor Point of Care Device

Interventions

Biosensor Point of Care Device DIAGNOSTIC_TEST

This device is a point of care urine-based metabolomic diagnostic test that detects metabolite biomarkers for CRC and polyps.

Phase 2 Field Test; Phase 2 Validation Study Cohort 1; Phase 2 Validation Study Cohort 2; Phase 2 Validation Study Cohort 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Obafemi Awolowo University Teaching Hospital: lead
• Memorial Sloan Kettering Cancer Center: collaborator

Study Sites (5)

Endoscopy Unit, University of Ilorin Teaching Hospital

Ilorin, Kwara State, Nigeria

Location

Federal Medical Center

Owo, Ondo State, Nigeria

Location

Endoscopy Unit, University College Hospital

Ibadan, Osun State, Nigeria

Location

Endoscopy Unit, Obafemi Awolowo University Teaching Hospitals

Ile-Ife, Osun State, 220005, Nigeria

Location

Ladoke Akintola University Teaching Hospital

Osogbo, Osun State, Nigeria

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

A urine sample is collected with 3 weeks of their surgery or colonoscopy.

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: May 23, 2017
• First Posted: June 2, 2017
• Study Start: February 11, 2017
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 4, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share

Locations

NG (5)