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Accuracy and Predictive Values for Colorectal Cancer of Quantitative FIT in Symptomatic Patients in Primary Care

Sponsor
Region Örebro County (Other)
Overall Status
Recruiting
CT.gov ID
NCT05156307
Collaborator
Region Jämtland Härjedalen (Other), Region Östergötland (Other), Uppsala County Council, Sweden (Other), Dalarna County Council, Sweden (Other), Landstinget i Värmland (Other)
2,500
Enrollment
1
Location
36.4
Anticipated Duration (Months)
68.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to determine accuracy and predictive values for colorectal cancer of a faecal quantitative immunochemical test (FIT) in unselected symptomatic patients presenting in primary care. Main reference test will be linkage to a nationwide colorectal cancer registry.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This is a nationwide multi-centre study in primary care, Sweden. Patients from the age of 40 years and above presenting in primary care with symptoms associated with colorectal cancer prompting their GP to take actions are eligible.

    Consenting patients will fill out a short form on symptoms during last 4 weeks. They will provide 2 faecal samples from 2 different days. Samples will be analysed at any of three laboratories within 5 days using QuikRead go® (Aidian Oy). The analytical working range is 10-200 µg Hb/g faeces. The outcome will be reported as the concentration of first test (FIT

    1. and highest concentration of two tests (FIT max). The outcome of the study FIT will remain within the study and GPs must request a separate FOBT for clinical purposes.

    Reference test will be linkage to the Swedish Colorectal Cancer Registry (with in practice complete coverage) after at most 2 years for all patients. Accuracy and predictive values will be determined and ROC-curves analysed.

    Some patients included in the study will be referred for colonoscopy for clinical reasons, and the outcome of FIT in relation to colonoscopy findings will be reported for this group as well.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    2500 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Accuracy and Predictive Values for Colorectal Cancer of a Quantitative Faecal Immunochemical Test in Symptomatic Patients in Primary Care
    Actual Study Start Date :
    May 20, 2021
    Anticipated Primary Completion Date :
    Jun 1, 2023
    Anticipated Study Completion Date :
    Jun 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Colorectal cancer [2 years]

      Linkage to cancer registry

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    Patients presenting in primary care with symptoms associated with colorectal cancer prompting their GP to take actions are eligible.

    Exclusion Criteria:

    Referral for bowel examination for other reasons than symptoms. Not able to understand the instructions for participation.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Skebäcks VC Örebro Sweden 702 15

    Sponsors and Collaborators

    • Region Örebro County
    • Region Jämtland Härjedalen
    • Region Östergötland
    • Uppsala County Council, Sweden
    • Dalarna County Council, Sweden
    • Landstinget i Värmland

    Investigators

    • Principal Investigator: Louise Olsson, MD, PhD, Region Örebro län, Camtö

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Louise Olsson, MD, PhD, Region Örebro County
    ClinicalTrials.gov Identifier:
    NCT05156307
    Other Study ID Numbers:
    • 275691
    First Posted:
    Dec 14, 2021
    Last Update Posted:
    Dec 14, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Louise Olsson, MD, PhD, Region Örebro County
    Quantitative faecal immunochemical test, symptomatic, primary care
    Additional relevant MeSH terms:
    Colorectal Neoplasms

    Study Results

    No Results Posted as of Dec 14, 2021