Point of Care, Real-Time Urine Metabolomics Test to Diagnose Colorectal Cancers and Polyps in Low-and Middle-Income Countries

Colorectal Cancer Screening Clinical Trial

Official title:

Point of Care, Real-Time Urine Metabolomics Test to Diagnose Colorectal Cancers and Polyps in Low-and Middle-Income Countries

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05679960
• Other study ID #: NHREC/01/01/2007-18/10/2021
• Status: Suspended
• Phase: N/A
• Start date: August 15, 2022
• Est. completion date: March 31, 2025

Study information

• Verified date: April 2024
• Source: Obafemi Awolowo University Teaching Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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

I. 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 645
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

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.

Related Conditions & MeSH terms

• Colorectal Cancer Screening
• Colorectal Neoplasms

Intervention

Diagnostic Test:
• Urine PolypDx machine Versus Colonoscopy
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

Locations

Country	Name	City	State
Nigeria	Obafemi Awolowo University Teaching Hospital	Ife	Osun

Sponsors (4)

Lead Sponsor	Collaborator
Obafemi Awolowo University Teaching Hospital	Memorial Sloan Kettering Cancer Center, National Institutes of Health (NIH), University of Alberta

Country where clinical trial is conducted

Nigeria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	One month
Secondary	Sensitivity Urine PolypDx device in detecting colorectal cancer (CRC)	Proportion of those urine PolyDx device detects to have CRC that actually have CRC	One month
Secondary	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	One month
Secondary	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	One month
Secondary	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	One month