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

CECILIA CURVALE

Status: Unknown

Conditions: Colorectal Neoplasms

Treatments: Diagnostic Test: quantitative and qualitative iFOBTs

Study type: Observational

Funder types: Other

Identifiers

NCT04831632

091/2020

Details and patient eligibility

About

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.

Enrollment: 630 estimated patients

Sex: All

Ages: 50 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

630 participants in 1 patient group

people aged 50-75

Description:

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

Treatment:

Diagnostic Test: quantitative and qualitative iFOBTs