NCT05156307|Unknown
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Sponsor study identifier
observational
2,500
1 country
1
Study Start
May 20, 2021
Actual (reported)Primary Completion
June 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 20, 2021
Actual (reported)December 1, 2021
Actual (reported)December 14, 2021
Actual (reported)June 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Colorectal cancer
Linkage to cancer registry
2 years
Patients aged ≥ 40 years presenting in primary care with symptoms associated with colorectal cancer prompting their GP to take actions are eligible. This involves referral for any endoscopic or radiological examination of the large bowel, laboratory testing, including faecal occult blood test according to local routines, or clinical follow-up within soon. Both urgent referrals and patients planned for at least initial management in primary care are eligible, ie there will be no attempt to delimitate the study population based on any categorization of symptoms into "alarm" and "non-alarm" symptoms. The study population will be defined by primary care physicians´ clinical reasoning and assessment of colorectal cancer as a (more or less) possible diagnosis at the unique consultation.
Skebäcks VC
Örebro, 702 15, Sweden
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.
Louise Olsson, MD, PhD
Region Örebro län, Camtö
First Submitted
December 1, 2021
First Posted
December 14, 2021
Study Start
May 20, 2021
Actual (reported)Primary Completion
June 2023
Estimated (date passed)Validation of a microRNA-based Fecal (miRFec) Test for Colorectal Cancer Screening, Surveillance and Diagnosis
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
December 14, 2021
Record last verified: 2021-11
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Source: ClinicalTrials.gov.
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