Investigating rectal mucus for detecting cancers in the aero-digestive tract.
Feasibility Study to Investigate the Genomic and Epigenetic Changes in Rectal Mucus in Non-Colorectal Cancers of the Aero-Digestive Tract (ORI-EGI-03).
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 |
|---|---|
| Enrollment | 450 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Origin Sciences Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Exeter) |
| Trial ID | NCT05102110 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and over who can provide informed consent and do not have contraindications for proctoscopic examination.
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.
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 performed: While this approach is innovative, similar studies have not been widely reported, indicating that this may be a novel investigation.
Eligibility criteria
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 this trial is running
Exeter
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.