Colorectal Cancer ScreeningNCT05679960
Point of Care, Real-Time Urine Metabolomics Test to Diagnose Colorectal Cancers and Polyps in Low-and Middle-Income Countries
A study testing Urine PolypDx machine Versus Colonoscopy in people with Colorectal Cancer Screening, run by Obafemi Awolowo University Teaching Hospital at 1 site in Nigeria.
Trial summary
Study description: the study is a clinical trial aimed at assessing the validity of a point-of-care tool developed for colorectal cancer screening using urine metabolites. Objectives: Primary Objective: In the pilot phase, investigators will field test the POC device in Nigeria on 75 patients who are high-risk for CRC… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer Screening
- What is being tested?
- Urine PolypDx machine Versus Colonoscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 645 participants
- Where
- 1 siteNigeria
- Study dates
- 15 Aug 2022to 31 Mar 2025
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients > 40 years of age with LGI bleeding for more than one week OR
- Patients who are high risk due to a family history of CRC (first-degree relative)
- 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)
- Patients with a diagnosis of stage I-III CRC who have no evidence of disease
Who cannot join
- 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 that the anesthesiologist or surgeon determines is a contraindication for colonoscopy in their facility.
- 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
1 site in 1 country.
Nigeria1 site
Obafemi Awolowo University Teaching Hospital
Ile-Ife, Osun State, 220005
About this study
Study description: the study is a clinical trial aimed at assessing the validity of a point-of-care tool developed for colorectal cancer screening using urine metabolites.
Objectives:
Read more
Primary Objective:
In the pilot phase, investigators will field test the POC device in Nigeria on 75 patients who are high-risk for CRC and then validate the urine metabolite signature using a large cohort of 645 patients at high risk for CRC and polyps. This will allow us to determine the sensitivity and specificity of this device and these signatures for CRC and polyps.
Endpoints: the endpoint will be the calculation of the validity (sensitivity and specificity) of the tool. Positive and negative predictive values will also be calculated.
Study population:
Patients > 40 years of age with LGI bleeding for more than one-week OR
- Patients who are high risk due to a family history of CRC (first-degree relative)
- 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)
- Patients with a diagnosis of stage I-III CRC who have no evidence of disease Both males and females will be involved in the study
- The study will evaluate the validity and acceptability of the POC biosensor device in Nigeria.
Description of sites/facilities enrolling participants: the study will be conducted at Obafemi Awolowo University Teaching Hospitals Complex (OAUTHC) which hosts the head office of African Research Group for Oncology (ARGO). The study will also run concurrently at other ARGO collaborating sites. All the ARGO collaborating sites are tertiary health care facilities with experienced personnel to oversee the study. The pilot study will, however, take place in OAUTHC alone.
Study duration:
The accrual time for the validation study is 2.5 years. Participant Duration: the study will require initial one-time contact. Those that are positive during the screening with the POC biosensor device will be booked for colonoscopy. Hence, for participants with positive results to complete the study may require 2 weeks on average.
- Conditions
- Colorectal Cancer Screening
- Being tested
- Urine PolypDx machine Versus Colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urine PolypDx machine Versus ColonoscopyDiagnostic test
- Urine samples of the participants in each group will be analyzed to check for preidentified metabolites that signified colorectal cancer
- Colonoscopy, which is the gold standard for colorectal cancer diagnosis/screening will be performed on all the participants positive for metabolites signifying CRC on Urine PolypDx machine in all the groups
| Study group | Role | What they receive |
|---|---|---|
| Patients low gastrointestinal tract bleeding | Active comparator | Patients presenting in the surgical outpatients or emergency department with low gastrointestinal tract bleeding Receives: Diagnostic Test: Urine PolypDx machine Versus Colonoscopy |
| Participants who are high risk due to a family history of CRC | Active comparator | First degree relatives of patients diagnosed with colorectal cancer Receives: Diagnostic Test: Urine PolypDx machine Versus Colonoscopy |
| Patients with a diagnosis of stage I-III CRC who have no evidence of disease | Active comparator | Patients previously diagnosed of stage I-III CRC and managed in the hospital but are now having no evidence of disease Receives: Diagnostic Test: Urine PolypDx machine Versus Colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Urine PolypDx device in detecting colorectal cancer
Results from the urine assay will be compared with the histology report of the tissue taken during colonoscopy, the gold standard for colorectal cancer diagnosis. Sensitivity, specificity, positive predictive value, and negative predictive values will be calculated
Measured: One month
Secondary outcomes (4)
Sensitivity Urine PolypDx device in detecting colorectal cancer (CRC)
Proportion of those urine PolyDx device detects to have CRC that actually have CRC
Measured: One month
Specificity Urine PolypDx device in detecting colorectal cancer (CRC)
Proportion of those urine PolyDx device detects not to have CRC that actually do not have CRC
Measured: One month
Positive Predictive Value Urine PolypDx device in detecting colorectal cancer (CRC)
Proportion of those who test positive with urine PolyDx device that actually do have CRC that actually have CRC
Measured: One month
Negative Predictive Value Urine PolypDx device in detecting colorectal cancer (CRC)
Proportion of those who test negative with urine PolyDx device that actually do not have CRC that actually have CRC
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start15 Aug 2022
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Why it stopped: The urine POC device seems not to be promising in colorectal cancer screening
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer ScreeningStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 645 participants (actual)
Sponsor and investigators
- Lead sponsor
- Obafemi Awolowo University Teaching Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Memorial Sloan Kettering Cancer Center, University of Alberta, National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Olusegun Alatise, Obafemi Awolowo University Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05679960
- Sponsor's protocol ID
- NHREC/01/01/2007-18/10/2021
- Status last verified
- Apr 2024
- First submitted
- 26 Jul 2022
- Last updated
- 5 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data (IPD) will be shared
Study at a glance
From the registry record, last updated by the sponsor on 5 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
- NCT05679960
- Acronym / sponsor ID
- NHREC/01/01/2007-18/10/2021
- Conditions
- Colorectal Cancer Screening
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: The urine POC device seems not to be promising in colorectal cancer screening
- Enrolment
- 645 participants (actual)
- Lead sponsor
- Obafemi Awolowo University Teaching HospitalUniversity, hospital or other
- Collaborators
- Memorial Sloan Kettering Cancer Center, University of Alberta, National Institutes of Health (NIH)
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 11 Jan 2023 (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.
Study description: the study is a clinical trial aimed at assessing the validity of a point-of-care tool developed for colorectal cancer screening using urine metabolites.
Objectives:
Primary Objective:
In the pilot phase, investigators will field test the POC device in Nigeria on 75 patients who are high-risk for CRC and then validate the urine metabolite signature using a large cohort of 645 patients at high risk for CRC and polyps. This will allow us to determine the sensitivity and specificity of this device and these signatures for CRC and polyps.
Endpoints: the endpoint will be the calculation of the validity (sensitivity and specificity) of the tool. Positive and negative predictive values will also be calculated.
Study population:
Patients > 40 years of age with LGI bleeding for more than one-week OR
- Patients who are high risk due to a family history of CRC (first-degree relative)
- 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)
- Patients with a diagnosis of stage I-III CRC who have no evidence of disease Both males and females will be involved in the study
- The study will evaluate the validity and acceptability of the POC biosensor device in Nigeria.
Description of sites/facilities enrolling participants: the study will be conducted at Obafemi Awolowo University Teaching Hospitals Complex (OAUTHC) which hosts the head office of African Research Group for Oncology (ARGO). The study will also run concurrently at other ARGO collaborating sites. All the ARGO collaborating sites are tertiary health care facilities with experienced personnel to oversee the study. The pilot study will, however, take place in OAUTHC alone.
Study duration:
The accrual time for the validation study is 2.5 years. Participant Duration: the study will require initial one-time contact. Those that are positive during the screening with the POC biosensor device will be booked for colonoscopy. Hence, for participants with positive results to complete the study may require 2 weeks on average.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients low gastrointestinal tract bleeding | Active comparator | Diagnostic Test: Urine PolypDx machine Versus ColonoscopyPatients presenting in the surgical outpatients or emergency department with low gastrointestinal tract bleeding |
| Participants who are high risk due to a family history of CRC | Active comparator | Diagnostic Test: Urine PolypDx machine Versus ColonoscopyFirst degree relatives of patients diagnosed with colorectal cancer |
| Patients with a diagnosis of stage I-III CRC who have no evidence of disease | Active comparator | Diagnostic Test: Urine PolypDx machine Versus ColonoscopyPatients previously diagnosed of stage I-III CRC and managed in the hospital but are now having no evidence of disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients > 40 years of age with LGI bleeding for more than one week OR
- Patients who are high risk due to a family history of CRC (first-degree relative)
- 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)
- Patients with a diagnosis of stage I-III CRC who have no evidence of disease
Key exclusion criteria (8 listed)
- 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 that the anesthesiologist or surgeon determines is a contraindication for colonoscopy in their facility.
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 |
|---|---|---|
| Urine PolypDx machine Versus Colonoscopy1. Urine samples of the participants in each group will be analyzed to check for preidentified metabolites that signified colorectal cancer 2. Colonoscopy, which is the gold standard for colorectal cancer diagnosis/screening will be performed on all the participants positive for metabolites signifying CRC on Urine PolypDx machine in all the groups | Diagnostic test | Participants who are high risk due to a family history of CRC, Patients low gastrointestinal tract bleeding, Patients with a diagnosis of stage I-III CRC who have no evidence of disease |
Primary outcome
Accuracy of Urine PolypDx device in detecting colorectal cancer
Time frame: One month
Results from the urine assay will be compared with the histology report of the tissue taken during colonoscopy, the gold standard for colorectal cancer diagnosis. Sensitivity, specificity, positive predictive value, and negative predictive values will be calculated
4 secondary outcomes
Sensitivity Urine PolypDx device in detecting colorectal cancer (CRC)
Time frame: One month
Specificity Urine PolypDx device in detecting colorectal cancer (CRC)
Time frame: One month
Positive Predictive Value Urine PolypDx device in detecting colorectal cancer (CRC)
Time frame: One month
Negative Predictive Value Urine PolypDx device in detecting colorectal cancer (CRC)
Time frame: One month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
- Individual participant dataSharing planned: Yes. All individual participant data (IPD) will be shared
Related trials for Colorectal Cancer Screening
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Not yet recruiting
Improving Colorectal Cancer Screening Uptake Through Education and Stool-Based Testing Outreach
Colorectal Cancer (CRC) Screening, CRC Screening
Active, not recruitingObservational study
Prostate Lung Colorectal and Ovarian (PLCO) Cancer Screening Trial
Cancer, Death
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
RecruitingObservational study
cfDNA Assay Prospective Observational Validation for Early Cancer Detection and Minimal Residual Disease
Brain Cancer, Breast Cancer
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urine PolypDx machine Versus Colonoscopy in people with Colorectal Cancer Screening, run by Obafemi Awolowo University Teaching Hospital at 1 site 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 8 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: paused, as of the sponsor's last update on 5 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 1 site 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?
Results are not available in the source record.
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?
Accuracy of Urine PolypDx device in detecting colorectal cancer (time frame: One month). 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 5 Apr 2024.