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.
Brief Title
Point of Care Test to Diagnosed Colorectal Cancer and Polyps in Low Middle Income Countries
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.
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Colorectal Cancer
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.
* 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.
Inclusion 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
* 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
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03173729
Org Class
Other
Org Full Name
Obafemi Awolowo University Teaching Hospital
Org Study Id
ERC/2017/02/11
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Point of Care, Real-time Urine Metabolomics Test to Diagnose Colorectal Cancers and Polyps in Low and Middle Income Countries
Primary Outcomes
Outcome Description
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.
Outcome Measure
Sensitivity and specificity of a point of care device to diagnose colorectal cancer and polyps
Outcome Time Frame
5 years
Secondary Outcomes
Outcome Description
The barriers and attitudes of patients towards a point of care urine test will be used to predict how many patients are willing to use this methodology.
Outcome Time Frame
3 years
Outcome Measure
Number of patients that are willing to consider continued colorectal cancer surveillance with a urine point of care test.
Outcome Description
The cost per patient will be determined using a cost effectiveness model already developed for the urine screening test in high-income countries.
Outcome Time Frame
3 years
Outcome Measure
Cost per patient of point of care urine test for diagnosing patients with colorectal cancer and polyps.
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
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
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
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Philip Castle
Investigator Email
philip.castle@einsteinmed.org
Investigator Phone