Colorectal CancerTRIOMICNCT06649123
Triple Assay of Rectal Mucus in the Diagnosis of Colorectal Cancer
An observational study of Colorectal Cancer and Adenoma Colon Polyp, run by Origin Sciences at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Colorectal Cancer, Adenoma Colon Polyp
- What is being tested?
- Oricol Test
- How many people
- 6,600 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2024to 1 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Up to 6600 patients referred through the UK Urgent Suspected Cancer Pathway.
Who may be able to join
- 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.
Who cannot join
- Patients who are unable to undergo digital rectal examination (DRE).
- 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
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- Post- operative anal stenosis
- The presence of an obstructing anal/low rectal tumour or discomfort as a result of previous pelvic radiotherapy
- Current pregnancy or suspicion of pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Shrewsbury & Telford NHS Foundation Trust
Telford, Shropshire, TF33DD
Jon Lacy-Colson, FRCS, +44(0)1952 282993, jon.lacy-colson@nhs.net
About this study
Official title: 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
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.
Read the detailed description
The primary objectives of the study are:
- Confirm the presence of established genetic, epigenetic and microbiome based biomarker signatures associated with CRC and high-risk adenoma (defined as >10mm in diameter or the presence of high-grade dysplasia) in colorectal urgent suspected cancer referrals, who are triaged for colonoscopy.
- 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.
- 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.
The Secondary Objectives of the study are:
- 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.
- Conditions
- Colorectal Cancer, Adenoma Colon Polyp
- Being tested
- Oricol Test
- Keywords
- colon, rectum, mucus, adenoma, microbiome
- Medical subject headings
- Colorectal Neoplasms, Adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oricol TestDiagnostic test
Assessment of diagnostic accuracy of Oricol Sampling device for triage in patients with suspected lower gastrointestinal cancer
What is being measured
The primary outcome is the main question the study is designed to answer.
TRIOMIC - 1
Determination of the clinical utility for stratification of colorectal cancer and high risk adenoma in a symptomatic population using hologenomic analysis.
Measured: 26 months
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.
Measured: 26 month
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.
Measured: 26 months
Secondary outcomes (1)
Health Economic Assessment
- 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.
Measured: 26 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start1 Nov 2024
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Origin Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shrewsbury and Telford Hospitals NHS Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06649123
- Sponsor's protocol ID
- Oricol-EGI-04
- Acronym
- TRIOMIC
- Status last verified
- Apr 2025
- First submitted
- 16 Oct 2024
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: As this study is supporting development of assay for diagnostics, the data will not be shared until completion of the research.
Publications
Humphrey HN, Diodato A, Isner JC, Walker E, Lacy-Colson J, Nedjai B, Daniels IR; ORI-EGI-02 Study Group. An internal pilot study of a novel rectal mucocellular sampling device to allow next-generation sequencing for colorectal disease. Tech Coloproctol. 2023 Mar;27(3):227-235. doi: 10.1007/s10151-022-02704-y. Epub 2022 Sep 27.
PubMed 36166177
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06649123
- Acronym / sponsor ID
- TRIOMIC / Oricol-EGI-04
- Conditions
- Colorectal Cancer, Adenoma Colon Polyp
- Keywords
- colon, rectum, mucus, adenoma, microbiome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 6,600 participants (estimated)
- Lead sponsor
- Origin SciencesIndustry (pharma, biotech, devices)
- Collaborators
- Shrewsbury and Telford Hospitals NHS Trust
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 18 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Confirm the presence of established genetic, epigenetic and microbiome based biomarker signatures associated with CRC and high-risk adenoma (defined as >10mm in diameter or the presence of high-grade dysplasia) in colorectal urgent suspected cancer referrals, who are triaged for colonoscopy.
- 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.
- 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.
The Secondary Objectives of the study are:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Up to 6600 patients referred through the UK Urgent Suspected Cancer Pathway.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- Patients who are unable to undergo digital rectal examination (DRE).
- 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:
- Current pregnancy or suspicion of pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oricol TestAssessment of diagnostic accuracy of Oricol Sampling device for triage in patients with suspected lower gastrointestinal cancer | Diagnostic test | – |
Primary outcome
TRIOMIC - 1
Time frame: 26 months
Determination of the clinical utility for stratification of colorectal cancer and high risk adenoma in a symptomatic population using hologenomic analysis.
TRIOMIC - 2
Time frame: 26 month
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.
TRIOMIC - 3
Time frame: 26 months
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.
1 secondary outcome
Health Economic Assessment
Time frame: 26 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Results publication: PubMed 36166177Humphrey HN, Diodato A, Isner JC, Walker E, Lacy-Colson J, Nedjai B, Daniels IR; ORI-EGI-02 Study Group. An internal pilot study of a novel rectal mucocellular sampling device to allow next-generation sequencing for colorectal disease. Tech Coloproctol. 2023 Mar;27(3):227-235. doi: 10.1007/s10151-022-02704-y. Epub 2022 Sep 27.
- Individual participant dataSharing planned: No. As this study is supporting development of assay for diagnostics, the data will not be shared until completion of the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Adenoma Colon Polyp, run by Origin Sciences at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jon Lacy-Colson, FRCS (+44(0)1743261000, jon.lacy-colson@sath.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TRIOMIC - 1 (time frame: 26 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06649123, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.