Feasibility Study to Investigate Rectal Mucus in Aero-Digestive Tract Cancer.
Recruiting · NCT05102110 · Observational (researchers observe without assigning treatment) · Lead sponsor: Origin Sciences
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The aim of the study is to assess the feasibility of genomic and epigenetic analysis of rectal mucus to detect non-colorectal cancers of the aero- digestive tract using samples collected by the OriCol™ Sampling Device. The primary objective of the study is to assess whether significant changes in DNA mutation and methylation associated with Non-colorectal cancers of the Aero-digestive Tract (NCRCADT) can be detected in rectal mucus as shed cells and cell-free DNA (cfDNA) pass through the gut and theoretically can be collected from rectal mucus. Secondary objectives will assess the participant acceptability of the OriCol™ Sampling Device for Pancreatic Ductal Adenocarcinoma, Non-Small Cell Cancer of the Lung, Colorectal Cancer and Urological Cancer controls as well as contributing to a genomic library collating information about rectal mucus.
Who can take part
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 is running
2 locations listed.
- Royal Devon & Exeter NHS Foundation Trust - Exeter, United Kingdom
- Royal Devon & Exeter NHS Foundation Trust - Exeter, United Kingdom