Diagnostic Performance Assessment of Qualitative Ifobt and Quantitative Ifobt for Advanced Neoplastic
1 other identifier
observational
630
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 1, 2021
CompletedFirst Posted
Study publicly available on registry
April 5, 2021
CompletedStudy Start
First participant enrolled
May 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedApril 8, 2021
April 1, 2021
1.7 years
April 1, 2021
April 5, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
qualitative iFOBT positivity rate
2 years
Study Arms (1)
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
Interventions
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 Criteria
people who belong to Hospital El Cruce's coverage area
You may qualify if:
- men and women aged 50-75
- Hospital El Cruce's coverage area and
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CECILIA CURVALElead
- Ministry of Public Health, Argentinacollaborator
Study Sites (1)
Hospital El Cruce
San Juan Bautista, Buenos Aires, 1888, Argentina
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Clinical Investigator
Study Record Dates
First Submitted
April 1, 2021
First Posted
April 5, 2021
Study Start
May 1, 2021
Primary Completion
December 31, 2022
Study Completion
December 31, 2022
Last Updated
April 8, 2021
Record last verified: 2021-04