4-week Serial FIT Analysis in Patients With CRC

NCT04242901 | Completed DMC

• 1 other identifier: 19ON031
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Cancer

Keywords

FIT; Symptomatic FIT

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• 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

Study Arms (1)

Colorectal cancer

Patients recently diagnosed colorectal cancer

Diagnostic Test: Faecal Immunochemical Test - OC Sensor, Eiken, Tokyo

Interventions

Faecal Immunochemical Test - OC Sensor, Eiken, Tokyo DIAGNOSTIC_TEST

Quantitative Faecal Immunochemical Test - OC Sensor, Eiken, Tokyo

Colorectal cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Histologically confirmed colorectal cancer

You may not qualify if:

• 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

Sponsors & Collaborators

• Nottingham University Hospitals NHS Trust: lead

Study Sites (1)

Queens Medical Centre

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• David Humes, MBBS

  Nottingham University Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2020
• First Posted: January 27, 2020
• Study Start: October 20, 2020
• Primary Completion: February 7, 2023
• Study Completion: February 7, 2023
• Last Updated: May 6, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)