Accuracy and Predictive Values for Colorectal Cancer of Quantitative FIT in Symptomatic Patients in Primary Care
NCT ID: NCT05156307
Last Updated: 2021-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
2500 participants
OBSERVATIONAL
2021-05-20
2024-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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OTHER
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
40 Years
ALL
No
Sponsors
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Region Jämtland Härjedalen
OTHER
Region Östergötland
OTHER
Uppsala County Council, Sweden
OTHER_GOV
Dalarna County Council, Sweden
OTHER
Landstinget i Värmland
OTHER
Region Örebro County
OTHER
Responsible Party
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Louise Olsson
MD, PhD
Principal Investigators
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Louise Olsson, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Region Örebro län, Camtö
Locations
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Skebäcks VC
Örebro, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Anna Lööv, MD
Role: primary
References
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Loov A, Hogberg C, Lilja M, Theodorsson E, Hellstrom P, Metsini A, Olsson L. Diagnostic accuracy for colorectal cancer of a quantitative faecal immunochemical test in symptomatic primary care patients: a study protocol. Diagn Progn Res. 2022 Aug 18;6(1):16. doi: 10.1186/s41512-022-00129-7.
Other Identifiers
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275691
Identifier Type: -
Identifier Source: org_study_id