Health TrialsbyHealthPanel

Triple Assay of Rectal Mucus in the Diagnosis of Colorectal Cancer

ConditionsColorectal CancerAdenoma Colon Polyp
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorOrigin Sciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients 18 years and over

Patients referred from primary care to the 'urgent suspected cancer' CRC pathway during the study period.

Patients who provide voluntary written informed consent to participate in the study.

Disqualifiers

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

Patients who have undergone radiotherapy.

An acute or chronic anal fissure

Perianal haematoma

Trial population

Up to 6600 patients referred through the UK Urgent Suspected Cancer Pathway.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Oricol Test

    Diagnostic test

    Assessment of diagnostic accuracy of Oricol Sampling device for triage in patients with suspected lower gastrointestinal cancer

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

TRIOMIC - 1

Determination of the clinical utility for stratification of colorectal cancer and high risk adenoma in a symptomatic population using hologenomic analysis.

Time frame
26 months
2

TRIOMIC - 2

To expand and refine the genomic, epigenetic and microbiome biomarker signature profiles associated with colorectal cancer and high-risk adenoma to identify rarer biomarkers in addition to those previously established.

Time frame
26 month
3

TRIOMIC - 3

To generate indicative performance metrics, including an assessment of discriminatory power, sensitivity, specificity and negative predictive values for the clinical application of Oricol™ multiomics assay.

Time frame
26 months

Secondary outcomes

1

Health Economic Assessment

1\. To assess the health economics of delivering a diagnostic service to patients referred to the urgent suspected cancer (USC) pathway via a Community Diagnostic Centre (CDC) in comparison to the current delivery mechanisms through the Two-Week Wait (TWW) pathway.

Time frame
26 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Origin Sciences

Lead sponsor

Shrewsbury and Telford Hospitals NHS Trust

Collaborator

Source ClinicalTrials.gov
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