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

Colorectal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04831632
• Other study ID #: 091/2020
• Status: Not yet recruiting
• Start date: May 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2021
• Source: Hospital El Cruce
• Contact: Raúl Matanó, Doctor
• Phone: 5492214203306
• Email: raulfmatano[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 630
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Argentina	Hospital El Cruce	Florencio Varela	Buenos Aires

Sponsors (2)

Lead Sponsor	Collaborator
CECILIA CURVALE	Ministry of health of the nation, Argentina

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	qualitative iFOBT positivity rate	To set the qualitative iFOBT positivity rate at 50 ng/mL in a controlled Argentine cohort.	2 years