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4-week Serial FIT Analysis in Patients With CRC

NCT04242901 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 58

Last updated 2023-05-06

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

Faecal Immunochemical Test - OC Sensor, Eiken, Tokyo

Quantitative Faecal Immunochemical Test - OC Sensor, Eiken, Tokyo

Sponsors & Collaborators

  • Nottingham University Hospitals NHS Trust

    lead OTHER

Principal Investigators

  • David Humes, MBBS · Nottingham University Hospitals NHS Trust

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-20
Primary Completion
2023-02-07
Completion
2023-02-07

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04242901 on ClinicalTrials.gov