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Trial record 4 of 32219 for:    POINT

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

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ClinicalTrials.gov Identifier: NCT03173729
Recruitment Status : Recruiting
First Posted : June 2, 2017
Last Update Posted : June 2, 2017
Sponsor:
Collaborator:
Memorial Sloan Kettering Cancer Center
Information provided by (Responsible Party):
Olusegun Alatise, Obafemi Awolowo University Teaching Hospital

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.

Condition or disease Intervention/treatment
Colorectal Cancer Diagnostic Test: Biosensor Point of Care Device

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 Type : Observational
Estimated Enrollment : 1170 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Point of Care, Real-time Urine Metabolomics Test to Diagnose Colorectal Cancers and Polyps in Low and Middle Income Countries
Actual Study Start Date : February 11, 2017
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


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

Phase 2 Validation Study Cohort 1
Family history of CRC (n = 330)
Diagnostic Test: Biosensor Point of Care Device
This device is a point of care urine-based metabolomic diagnostic test that detects metabolite biomarkers for CRC and polyps.

Phase 2 Validation Study Cohort 2
LGI bleeding (n = 240)
Diagnostic Test: Biosensor Point of Care Device
This device is a point of care urine-based metabolomic diagnostic test that detects metabolite biomarkers for CRC and polyps.

Phase 2 Validation Study Cohort 3
Patients with history of CRC (n = 75)
Diagnostic Test: Biosensor Point of Care Device
This device is a point of care urine-based metabolomic diagnostic test that detects metabolite biomarkers for CRC and polyps.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Number of patients that are willing to consider continued colorectal cancer surveillance with a urine point of care test. [ Time Frame: 3 years ]
    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.

  2. Cost per patient of point of care urine test for diagnosing patients with colorectal cancer and polyps. [ Time Frame: 3 years ]
    The cost per patient will be determined using a cost effectiveness model already developed for the urine screening test in high-income countries.


Biospecimen Retention:   Samples Without DNA
A urine sample is collected with 3 weeks of their surgery or colonoscopy.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03173729


Contacts
Contact: Olusegun Alatise, MD 2348033859387 segunalatishe@gmail.com
Contact: T. Peter Kingham, MD 212-639-5260 KinghamT@mskcc.org

Locations
Nigeria
Endoscopy Unit, University of Ilorin Teaching Hospital Not yet recruiting
Ilorin, Kwara State, Nigeria
Contact: Ademola A Adeyeye, FWACS    234 810 101 5373    adeyeye_ademola@yahoo.com   
Federal Medical Center Not yet recruiting
Owo, Ondo State, Nigeria
Contact: Abba Katung, FWACS    234 807 395 7453    katungaba@yahoo.co.uk   
Endoscopy Unit, University College Hospital Not yet recruiting
Ibadan, Osun State, Nigeria
Contact: Omobolaji O Ayandipo, FWACS    234 805 124 9319    yokebukola@yahoo.com   
Ladoke Akintola University Teaching Hospital Not yet recruiting
Osogbo, Osun State, Nigeria
Contact: Oladapo Kolawole, FWACS    234 802 385 9166    cullerwarley@yahoo.co.uk   
Endoscopy Unit, Obafemi Awolowo University Teaching Hospitals Recruiting
Ile Ife, Osun, Nigeria, 220005
Contact: Olusegun I Alatise, FWACS    2348033859387    segunalatishe@gmail.com   
Sponsors and Collaborators
Obafemi Awolowo University Teaching Hospital
Memorial Sloan Kettering Cancer Center

Responsible Party: Olusegun Alatise, Dr, Obafemi Awolowo University Teaching Hospital
ClinicalTrials.gov Identifier: NCT03173729     History of Changes
Other Study ID Numbers: ERC/2017/02/11
First Posted: June 2, 2017    Key Record Dates
Last Update Posted: June 2, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Will follow the NIH/NCI approved guidelines

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases