4-week Serial FIT Analysis in Patients With CRC
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|ClinicalTrials.gov Identifier: NCT04242901|
Recruitment Status : Not yet recruiting
First Posted : January 27, 2020
Last Update Posted : January 29, 2020
Assimilation of FIT into primary and secondary care diagnostic pathways will lead to an increased prominence of the investigation in the diagnosis of colorectal cancer (CRC). Questions remain about whether serial FIT analysis improves accuracy, and what factors affect it.
Our study will analyse FIT results in recently diagnosed CRC patients to determine the risk of a false-negative FIT result and evaluate whether repeated analysis improves diagnostic accuracy. The study aims to advise on whether there is an optimal interval between sample collection to improve diagnostic accuracy and whether any patients are at risk of a false negative based on demographics, medications or other pathological factors.
|Condition or disease||Intervention/treatment|
|Colorectal Cancer||Diagnostic Test: Faecal Immunochemical Test - OC Sensor, Eiken, Tokyo|
Colorectal cancer (CRC) remains a leading cause of cancer death in the UK and worldwide. Improving outcomes depends in part on achieving earlier diagnosis of the disease.
The Faecal Immunochemical Test (FIT) is replacing the less accurate Faecal Occult Blood Test (FOBT) in the UK and has the potential to help achieve earlier stage diagnosis of CRC. Whilst FIT has been validated as a screening test for the Bowel Cancer Screening Programme (BCSP), its role in diagnosing CRC in symptomatic populations is yet to be defined.
Nottingham is a pioneering centre using FIT to stratify risk and determine first-investigation in its two-week-wait (2WW) pathway. To optimise use of FIT and minimise the chance of missed cancers, this project aims to better understand variation of FIT results over time and how certain factors affect FIT result.
Much of the literature has focused on the evaluation of FIT in an asymptomatic population, which is inherently low risk (4,6,7). Expanding use of FIT to stratify risk and guide investigations for cancer in (higher risk) symptomatic populations necessitates a thoroughly evaluated testing strategy. At present there is insufficient information to advise on "negative" FIT results in symptomatic patients. This study will comprehensively measure FIT variation over time in patients with the target condition (CRC) and help answer whether additional samples are likely to improve accuracy of FIT.
Risk factors for false positives and false negatives have been previously identified but are not widely established (4). Our study will record the presence of these risk factors, and evaluate their effects on FIT-positivity with subsequent statistical analysis.
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Serial Faecal Immunochemical Testing in Patients With Colorectal Cancer|
|Estimated Study Start Date :||February 2020|
|Estimated Primary Completion Date :||February 2022|
|Estimated Study Completion Date :||February 2022|
Patients recently diagnosed colorectal cancer
Diagnostic Test: Faecal Immunochemical Test - OC Sensor, Eiken, Tokyo
Quantitative Faecal Immunochemical Test - OC Sensor, Eiken, Tokyo
- False negative FIT results - Determine the occurrence of falsely negative FIT results in the presence of colorectal cancer [ Time Frame: 2 years ]Determine the occurrence of falsely negative FIT results in the presence of colorectal cancer
- Number of participants who yield sequential FIT results in divergent strata used for clinical decision making [ Time Frame: 2 years ]Number of participants who yield sequential FIT results in divergent strata used for clinical decision making (FIT <4 μg Hb/g faeces, 4-9.9 μg Hb/g faeces, 10-99.9 μg Hb/g faeces, 100-150 μg Hb/g faeces, >150 μg Hb/g faeces)
- Calculation of Odds Ratios for age, gender, family history of CRC, hypertension, obesity, smoking status, excessive alcohol intake, right sided tumour, stage 1 cancer [ Time Frame: 2 years ]Calculation of Odds Ratios for age, gender, family history of CRC, hypertension, obesity, smoking status, excessive alcohol intake, right sided tumour, stage 1 cancer
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04242901
|Contact: James Bailey, BMBSemail@example.com|
|Contact: David Humes, MBBSfirstname.lastname@example.org|
|Principal Investigator:||David Humes, MBBS||Nottingham University Hospitals NHS Trust|