Diagnostic Performance Assessment of Qualitative Ifobt and Quantitative Ifobt for Advanced Neoplastic

CECILIA CURVALE630 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

630

Conditions

Colorectal Neoplasms

Interventions

quantitative and qualitative iFOBTsDIAGNOSTIC_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.

Eligibility

Sex: ALLMin age: 50 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 2 years

Secondary Outcomes

qualitative iFOBT positivity rate

To set the qualitative iFOBT positivity rate at 50 ng/mL in a controlled Argentine cohort.