Exploratory Study of Rectal Mucus for Diagnosing Disease

NCT04659590 | Completed

• 1 other identifier: 263745
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 4

Brief Summary

The identification of patients with colorectal cancer is challenging as they present with a variable symptom profile and require invasive tests (colonoscopy) for diagnosis (through histological analysis of biopsies) and complimented by cross-sectional radiology, prior to commencement of treatment. The biopsy forms the basis of the diagnosis and management planning for a patient with colorectal cancer through the multidisciplinary team. The biggest challenge currently faced in the management of colorectal cancer is the accurate identification of patients who present with various symptoms none of which are specific for bowel cancer. Currently the NICE referral guidelines are used to determine the appropriateness of referral pathway, i.e. Fast-Track/Two-Week Wait referral. A recent review of over 10000 referrals revealed a colorectal cancer diagnosis in 4.1% of referrals. Previous literature reports rates as high as 8%, but in series of cases with only 72-89% adherence to the referral guidance leading to at best 40% of all colorectal cases being diagnosed through this route. The remainder of colorectal cancers being diagnosed through the bowel cancer screening programme (NBCSP), non-two-week wait referrals and other processes such as emergency admissions. Inherently the Two-Week Wait pathway refers a large volume of "symptomatic patients" and it has become a "cancer exclusion pathway." Once cancer has been excluded, patients are often discharged back to General Practice, yet the patients often still have symptoms. The current Covid-19 pandemic has had a significant impact on the already pressed Two-Week pathway impacting on the reduction of endoscopic and radiological appointments available leading to delays in treatment. Each test performed in the diagnostic pathway has a significant financial, personal, and institutional resource profile. It is our aim to develop a novel diagnostic device based upon the identification of genetic mutations and genomic alterations from material trapped in the rectal mucous layer allowing focused endoscopic assessment, confirmation/exclusion of cancer diagnosis from cross-sectional imaging in those unfit for endoscopic examination and identification of high-risk lesions (dysplasia). This would allow a greater triage, and focus colonoscopic services onto therapeutic procedures, improving overall care.

Conditions

Bowel Cancer; Bowel Disease; Genomic; Epigenetic Disorder

Outcome Measures

Primary Outcomes (1)

• Stability of buffer transfer medium

  Sample loss rate

  through study, an average of 1 year

Secondary Outcomes (2)

• Comparison to qFiT test

  through study, an average of 1 year

• Comparison between tumour surface imprint and rectal mucous imprint

  through study, an average of 1 year

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with known or suspected gastrointestinal disease(s).

You may qualify if:

• aged 18 years or over
• be able to give voluntary, written informed consent to participate in the study

You may not qualify if:

• Subjects with confirmed collagenous colitis or symptoms that would make proctoscopic examination inappropriate, including acute anal fissure, symptomatic thrombosed haemorrhoids or obstructing anorectal tumours as determined by rectal examination
• Subjects with a previous history of cancer or who have previously received radiotherapy, chemotherapy or immunotherapy
• The following populations will be included:
• Subjects with confirmed colorectal cancer
• Subjects with suspected colorectal cancer
• Subjects with known or suspected inflammatory bowel disease
• Known controls

Sponsors & Collaborators

• Origin Sciences: lead

Study Sites (4)

Royal Cornwall Hospital

Truro, Cornwall, TR1 3LQ, United Kingdom

Location

John Radcliffe Hospital

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Location

Royal Shrewsbury & Telford Hospitals NHS Trust

Shrewsbury, Shropshire, SY3 8XQ, United Kingdom

Location

Royal Devon & Exeter NHS Foundation Trust

Exeter, EX2 4UG, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Banked DNA retrieved from specimen taken from bowel lumen

MeSH Terms

Conditions

Intestinal Neoplasms; Intestinal Diseases

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Study Officials

• Jon Lacy-Colson, FRCS

  Royal Shrewsbury Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 12, 2020
• First Posted: December 9, 2020
• Study Start: November 6, 2019
• Primary Completion: August 15, 2022
• Study Completion: August 15, 2023
• Last Updated: October 18, 2024

Record last verified: 2022-08

Locations

GB (4)