Status:

RECRUITING

Triple Assay of Rectal Mucus in the Diagnosis of Colorectal Cancer

Lead Sponsor:

Origin Sciences

Collaborating Sponsors:

Shrewsbury and Telford Hospitals NHS Trust

Conditions:

Colorectal Cancer

Adenoma Colon Polyp

Eligibility:

All Genders

18-99 years

Brief Summary

Development of a multiomics assay for use on OriColTM sampled rectal mucus for detection of cancer and significant polyps in symptomatic patients on the Colorectal Urgent Suspected Cancer pathway.

Detailed Description

The primary objectives of the study are: 1. Confirm the presence of established genetic, epigenetic and microbiome based biomarker signatures associated with CRC and high-risk adenoma (defined as \>1...

Eligibility Criteria

Inclusion Criteria:

  1. Patients 18 years and over
  2. Patients referred from primary care to the 'urgent suspected cancer' CRC pathway during the study period.
  3. Patients who provide voluntary written informed consent to participate in the study.

Exclusion Criteria:

  1. Patients who are unable to undergo digital rectal examination (DRE).

  2. Patients with peri-anal/anal symptoms that may limit DRE and proctoscopy examination and it would be clinically inappropriate to attempt to assess these patients. This may include conditions such as:

    • Patients who have undergone radiotherapy.
    • An acute or chronic anal fissure
    • Perianal haematoma
    • Acute thrombosed haemorrhoids
    • Post- operative anal stenosis
    • The presence of an obstructing anal/low rectal tumour or discomfort as a result of previous pelvic radiotherapy
  3. Current pregnancy or suspicion of pregnancy.

Key Trial Info

Start Date :

November 1 2024

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

April 1 2027

Estimated Enrollment :

6600 Patients enrolled

Trial Details

Trial ID

NCT06649123

Start Date

November 1 2024

End Date

April 1 2027

Last Update

April 4 2025

Active Locations (1)

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1

Shrewsbury & Telford NHS Foundation Trust

Telford, Shropshire, United Kingdom, TF33DD