Investigating rectal mucus for detecting cancers in the aero-digestive tract.
Official title: Feasibility Study to Investigate the Genomic and Epigenetic Changes in Rectal Mucus in Non-Colorectal Cancers of the Aero-Digestive Tract (ORI-EGI-03).
Run by Origin Sciences · NCT05102110 · Data updated 2026-11-12
This study is testing whether analyzing rectal mucus can help find cancers in the throat and digestive system for people who may need new ways to get diagnosed.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 99 Years |
| Sex | All |
| Enrollment | 450 (estimated) |
| Sponsor | Origin Sciences Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Exeter) |
| Status | Recruiting |
| Started | December 1, 2021 |
| Main results expected | July 30, 2027 |
| Study ends | December 1, 2027 |
| Registry record updated | March 16, 2026 |
| Trial ID | NCT05102110 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and over who can provide informed consent and do not have contraindications for proctoscopic examination.
✕Probably not a fit
Patients with a history of cancer or those who have undergone previous cancer treatments such as radiotherapy, chemotherapy, or immunotherapy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate the feasibility of using genomic and epigenetic analysis of rectal mucus to identify non-colorectal cancers in the aero-digestive tract. It involves collecting samples using the OriCol™ Sampling Device to assess changes in DNA mutation and methylation associated with these cancers. Additionally, the study will explore participant acceptability of the sampling device and contribute to a genomic library focused on rectal mucus. The research is motivated by the need for alternative diagnostic methods, especially highlighted during the Covid-19 pandemic.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive method for early detection of various cancers in the aero-digestive tract.
How similar studies have gone: While this approach is innovative, similar studies have not been widely reported, indicating that this may be a novel investigation.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: Aged 18 years or over Be able to give voluntary, written informed consent to participate in the study Exclusion Criteria: Participants with symptoms that would make proctoscopic examination inappropriate, including acute anal fissure, symptomatic thrombosed haemorrhoids or obstructing anorectal lesions as determined by rectal examination Participants with a previous history of cancer Participants who have received previously radiotherapy, chemotherapy or immunotherapy for a malignancy.
Where it's running
-
Royal Devon & Exeter NHS Foundation Trust
Exeter, United Kingdom Recruiting
Study contacts
- Study coordinator: Ian Daniels, FRCS
- Email: Ian.Daniels@originsciences.com
- Phone: 01223 750490
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.