Colorectal Neoplasms
Conditions
Keywords
screening, colorectal cancer, fecal immunochemical test, FIT accuracy
Brief summary
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.
Interventions
DIAGNOSTIC_TESTquantitative and qualitative iFOBTs
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.
Sponsors
Ministry of Public Health, Argentina
CECILIA CURVALE
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* men and women aged 50-75 * Hospital El Cruce's coverage area and
Exclusion criteria
* those that have taken part in a previous VCC screening in the 5 past years or in a CRC screening program the year before the recruitment * 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 * those refuse to sign the consent form to take part in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| diagnostic performance | 2 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| qualitative iFOBT positivity rate | 2 years | To set the qualitative iFOBT positivity rate at 50 ng/mL in a controlled Argentine cohort. |
Countries
Argentina
Contacts
Primary ContactRaúl Matanó, Doctor
Backup ContactCecilia Curvale, Doctor
Outcome results
None listed