Colorectal CancerNCT03173729
Point of Care Test to Diagnosed Colorectal Cancer and Polyps in Low Middle Income Countries
An observational study of Colorectal Cancer, run by Obafemi Awolowo University Teaching Hospital at 5 sites in Nigeria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Biosensor Point of Care Device
- How many people
- 926 participants
- Where
- 5 sitesNigeria
- Study dates
- 11 Feb 2017to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
5 sites in 1 country.
5 sites in 1 country
Nigeria5 sites
Endoscopy Unit, University College Hospital
Ibadan, Osun State
Endoscopy Unit, Obafemi Awolowo University Teaching Hospitals
Ile-Ife, Osun State, 220005
Endoscopy Unit, University of Ilorin Teaching Hospital
Ilorin, Kwara State
Ladoke Akintola University Teaching Hospital
Osogbo, Osun State
Federal Medical Center
Owo, Ondo State
About this study
Official title: Point of Care, Real-time Urine Metabolomics Test to Diagnose Colorectal Cancers and Polyps in Low and Middle Income Countries
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.
Read the 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.
- Conditions
- Colorectal Cancer
- Being tested
- Biosensor Point of Care Device
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biosensor Point of Care DeviceDiagnostic test
This device is a point of care urine-based metabolomic diagnostic test that detects metabolite biomarkers for CRC and polyps.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Biosensor Point of Care Device | |
| Phase 2 Validation Study Cohort 1 | Family history of CRC (n = 330) Receives: Diagnostic Test: Biosensor Point of Care Device | |
| Phase 2 Validation Study Cohort 2 | LGI bleeding (n = 240) Receives: Diagnostic Test: Biosensor Point of Care Device | |
| Phase 2 Validation Study Cohort 3 | Patients with history of CRC (n = 75) Receives: Diagnostic Test: Biosensor Point of Care Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Secondary outcomes (2)
Number of patients that are willing to consider continued colorectal cancer surveillance with a urine point of care test.
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.
Measured: 3 years
Cost per patient of point of care urine test for diagnosing patients with colorectal cancer and polyps.
The cost per patient will be determined using a cost effectiveness model already developed for the urine screening test in high-income countries.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2017
- Study start11 Feb 2017
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 926 participants (actual)
Sponsor and investigators
- Lead sponsor
- Obafemi Awolowo University Teaching Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Memorial Sloan Kettering Cancer Center
- Responsible party
- Principal investigator, Olusegun Alatise, Obafemi Awolowo University Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03173729
- Sponsor's protocol ID
- ERC/2017/02/11
- Status last verified
- Apr 2024
- First submitted
- 23 May 2017
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Will follow the NIH/NCI approved guidelines
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Point of Care, Real-time Urine Metabolomics Test to Diagnose Colorectal Cancers and Polyps in Low and Middle Income Countries
- ClinicalTrials.gov ID
- NCT03173729
- Acronym / sponsor ID
- ERC/2017/02/11
- Conditions
- Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 926 participants (actual)
- Lead sponsor
- Obafemi Awolowo University Teaching HospitalUniversity, hospital or other
- Collaborators
- Memorial Sloan Kettering Cancer Center
- Study start
- 11 Feb 2017 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 2 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Diagnostic Test: Biosensor Point of Care Device75 patients who are high risk for CRC as described in the eligibility |
| Phase 2 Validation Study Cohort 1 | – | Diagnostic Test: Biosensor Point of Care DeviceFamily history of CRC (n = 330) |
| Phase 2 Validation Study Cohort 2 | – | Diagnostic Test: Biosensor Point of Care DeviceLGI bleeding (n = 240) |
| Phase 2 Validation Study Cohort 3 | – | Diagnostic Test: Biosensor Point of Care DevicePatients with history of CRC (n = 75) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biosensor Point of Care DeviceThis device is a point of care urine-based metabolomic diagnostic test that detects metabolite biomarkers for CRC and polyps. | Diagnostic test | Phase 2 Field Test, Phase 2 Validation Study Cohort 1, Phase 2 Validation Study Cohort 2, Phase 2 Validation Study Cohort 3 |
Primary outcome
Sensitivity and specificity of a point of care device to diagnose colorectal cancer and polyps
Time frame: 5 years
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.
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
- Individual participant dataSharing planned: Yes. Will follow the NIH/NCI approved guidelines
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Obafemi Awolowo University Teaching Hospital at 5 sites in Nigeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of a point of care device to diagnose colorectal cancer and polyps (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2024.