4-week Serial FIT Analysis in Patients With CRC

Serial Faecal Immunochemical Testing in Patients With Colorectal Cancer

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Diagnostic test: Faecal Immunochemical Test - OC Sensor, Eiken, Tokyo

Detailed Description

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
• Enrollment (Actual): 58

Contacts and Locations

• Study Contact: Name: James Bailey, BMBS; Phone Number: 07856917071; Email: james.bailey4@nhs.net
• Study Contact Backup: Name: David Humes, MBBS; Phone Number: 01159249924; Email: david.humes@nuh.nhs.uk

Study Locations

• United Kingdom
  • Nottinghamshire
    • Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
      • Queens Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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.

Description

Inclusion Criteria:

• Histologically confirmed colorectal cancer

Exclusion Criteria:

• Less than 18 years old
• Not attending Nottingham University Hospitals for diagnosis/treatment (attending another trust)
• No histological diagnosis of colorectal cancer
• Unable to provide informed consent - for example due to language barriers or lacking capacity to join study

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Colorectal cancer; Patients recently diagnosed colorectal cancer	Diagnostic test: Faecal Immunochemical Test - OC Sensor, Eiken, Tokyo; Quantitative Faecal Immunochemical Test - OC Sensor, Eiken, Tokyo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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)	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	2 years

Collaborators and Investigators

• Sponsor: Nottingham University Hospitals NHS Trust
• Investigators: Principal Investigator: David Humes, MBBS, Nottingham University Hospitals NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2020
• Primary Completion (Actual): February 7, 2023
• Study Completion (Actual): February 7, 2023

Study Registration Dates

• First Submitted: January 9, 2020
• First Submitted That Met QC Criteria: January 24, 2020
• First Posted (Actual): January 27, 2020

Study Record Updates

• Last Update Posted (Estimate): May 4, 2023
• Last Update Submitted That Met QC Criteria: May 3, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: FIT; Symptomatic FIT
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 19ON031

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share individual participant data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No