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| Name | Class |
|---|---|
| Ministry of Public Health, Argentina | OTHER_GOV |
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In Argentina, there is vast experience in qualitative iFOBT population screening that is part of the CRC Prevention and Early Detection National Program. The screening's cut-off point is at 50 ng/mL buffer. Its positivity rate for 2019 has been an average of 26.15%, over the double of the one reported in the international literature (7.5-11%) for this cut-off point (1). There are no studies that assess such technology and suggest an appropriate cut-off point for this population. The goal of this study is to assess the diagnostic performance of the qualitative iFOBT used in the present and the quantitative iFOBT with various cut-off points for advanced neoplastic wound screening (colorectal cancer and advanced adenoma) in an Argentine patient cohort.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| people aged 50-75 | men and women aged 50-75 who belong to Hospital El Cruce's coverage area and do not have personal history of colorectal cancer or inflammatory bowel disease, personal or family history of syndromes of predisposition to known cancers, or family history of colorectal cancer in a first-degree relative aged less than 60 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| quantitative and qualitative iFOBTs | Diagnostic Test | They will have their qualitative and quantitative iFOBTs done within the week prior to the VCC study completion. The reading of both of them will be done in Hospital El Cruce's laboratory. The result of the qualitative iFOBT will have two valid expressions: positive or negative.The result of the quantitative iFOBT will be expressed as µg from hemoglobin per gram of fecal matter through the use of automatized equipment for laboratory analysis. |
| Measure | Description | Time Frame |
|---|---|---|
| diagnostic performance | To determine the diagnostic performance of the quantitative iFOBT with various cut-off points and the qualitative iFOBT, compared to the VCC, when detecting advanced colon neoplasms. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| qualitative iFOBT positivity rate | To set the qualitative iFOBT positivity rate at 50 ng/mL in a controlled Argentine cohort. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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people who belong to Hospital El Cruce's coverage area
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Raúl Matanó, Doctor | Contact | 5492214203306 | raulfmatano@hotmail.com | |
| Cecilia Curvale, Doctor | Contact | 5491140878193 | cecicurvale@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital El Cruce | San Juan Bautista | Buenos Aires | 1888 | Argentina |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |