An observational study in Colorectal Cancer, sponsored by Nottingham University Hospitals NHS Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-06.
Sponsored by Nottingham University Hospitals NHS Trust · Observational
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.
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.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 58 is below the median of 250 across 1,226 observational studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Nottingham University Hospitals NHS Trust is the lead sponsor of 104 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
200 patients will be recruited to the study. Nottingham University Hospitals NHS Trust diagnoses approximately 500 CRCs per year, yielding an available population pool of 1000 patients in the study period. A sample size of 200 participants (returning 1000 samples in total) represents a realistic recruitment target.
Exclusion Criteria:
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
Determine the occurrence of falsely negative FIT results in the presence of colorectal cancer
Time frame: 2 years
Number of participants who yield sequential FIT results in divergent strata used for clinical decision making
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)
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
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
Plan to share: No — No plan to share individual participant data
No publications or documents are linked to this record.
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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Nottingham University Hospitals NHS Trust