NCT04831632

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

Diagnostic Performance Assessment of Qualitative Ifobt and Various Quantitative Ifobt Cut-off Points for Advanced Neoplastic Wound Screening in an Argentine Patient Cohort

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 630 (estimated)
• Sponsor: CECILIA CURVALE · Academic / Other
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Colorectal Neoplasms

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	quantitative 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.

Timeline

• Start date: 2021-05-01
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2021-04-05
• Last updated: 2021-04-08

Locations

1 site across 1 country: Argentina