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Feasibility Study to Investigate Rectal Mucus in Aero-Digestive Tract Cancer.
Sponsor: Origin Sciences
Summary
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.
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).
Key Details
Gender
All
Age Range
18 Years - 99 Years
Study Type
OBSERVATIONAL
Enrollment
450
Start Date
2021-12-01
Completion Date
2027-12-01
Last Updated
2026-03-16
Healthy Volunteers
No
Interventions
Oricol Test
Assessment of rectal mucus for material from aero-digestive cancers.
Locations (1)
Royal Devon & Exeter NHS Foundation Trust
Exeter, United Kingdom