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

April 5, 2021 updated by: CECILIA CURVALE

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

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

630

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Argentina
    • Buenos Aires
      • Florencio Varela, Buenos Aires, Argentina, 1888
        • Hospital El Cruce

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

people who belong to Hospital El Cruce's coverage area

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
people aged 50-75
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
diagnostic performance
Time Frame: 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.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
qualitative iFOBT positivity rate
Time Frame: 2 years
To set the qualitative iFOBT positivity rate at 50 ng/mL in a controlled Argentine cohort.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CECILIA CURVALE

Collaborators

Ministry of Public Health, Argentina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2021

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

April 1, 2021

First Submitted That Met QC Criteria

April 1, 2021

First Posted (Actual)

April 5, 2021

Study Record Updates

Last Update Posted (Actual)

April 8, 2021

Last Update Submitted That Met QC Criteria

April 5, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 091/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Colorectal Neoplasms

Clinical Trials on quantitative and qualitative iFOBTs

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Colombia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe