Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

4-week Serial FIT Analysis in Patients With CRC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04242901
Recruitment Status : Not yet recruiting
First Posted : January 27, 2020
Last Update Posted : January 29, 2020
Sponsor:
Information provided by (Responsible Party):
Nottingham University Hospitals NHS Trust

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.


Condition or disease Intervention/treatment
Colorectal Cancer 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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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

  2. 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)


Secondary Outcome Measures :
  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 [ 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: James Bailey, BMBS 07856917071 james.bailey4@nhs.net
Contact: David Humes, MBBS 01159249924 david.humes@nuh.nhs.uk

Sponsors and Collaborators
Nottingham University Hospitals NHS Trust
Investigators
Layout table for investigator information
Principal Investigator: David Humes, MBBS Nottingham University Hospitals NHS Trust
Layout table for additonal information
Responsible Party: Nottingham University Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT04242901    
Other Study ID Numbers: 19ON031
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: January 29, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share individual participant data

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nottingham University Hospitals NHS Trust:
FIT
Symptomatic FIT
Additional relevant MeSH terms:
Layout table for MeSH terms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases