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The purpose of this study is to find out whether a urine test can detect colorectal cancer (CRC) and precancerous polyps in participants living in Ghana, Tanzania, and South Africa.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with Colorectal Cancer/CRC | Participants will either have symptoms of colorectal cancer/CRC, presented for a screening colonoscopy, or one of the following: pathologic diagnosis of CRC, colonoscopy demonstrating adenomatous polyps, or colonoscopy demonstrating no colon or premalignant or malignant pathology |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3-metabolite biosensor | Diagnostic Test | 3-metabolite biosensor will identify participants with colorectal cancer (CRC) and precancerous polyps |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of 3-metabolite biosensor | The study will validate a 3-metabolite biosensor that identifies participants with colorectal cancer (CRC) and precancerous polyps in Ghana, Tanzania and South Africa. The primary aim is to show that the sensitivity and specificity in other regions are as good as the Nigerian estimates (i.e. 90% and 80% respectively). | up to 1 year |
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Inclusion Criteria:
Patient presents with one of the following:
Patients with symptoms of CRC (such as rectal bleeding for a week) -OR-
Patients who present for a screening colonoscopy -OR-
Has received one of the following within 3 weeks of the planned urine collection
Age ≥ 18
Willingness to participate in the study
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Data and samples will be collected from 3 sites in Africa: Korle Bu Teaching Hospital/University of Ghana Medical School in Ghana; Kilimanjaro Christian Medical Centre in Tanzania and Wits Donald Gordon Medical Centre, Wits Donald Gordon Medical Research Institute in South Africa. Consent will occur at these sites.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peter Kingham, MD | Contact | 212-639-5260 | kinghamP@mskcc.org | |
| Alexia Iasonos, PhD | Contact | 646-227-3557 | iasonosa@mskcc.org |
| Name | Affiliation | Role |
|---|---|---|
| Peter Kingham, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center (All Protocol Activities) | Recruiting | New York | New York | 10065 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D006471 | Gastrointestinal Hemorrhage |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| Korle Bu Teaching Hospital (Data Collection Only) | Not yet recruiting | Accra | Ghana |
|
| Wits Donald Gordon Medical Centre (Data Collection Only) | Not yet recruiting | Johannesburg | South Africa |
|
| Kilimanjaro Christian Medical Centre (Data Collection Only) | Not yet recruiting | Moshi | Tanzania |
|
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |