ORI-EGI-03
Research type
Research Study
Full title
Feasibility Study to Investigate the Genomic and Epigenetic Changes within Rectal Mucus in Non-colorectal Cancers of the Aero-digestive Tract (ORI-EGI-03)
IRAS ID
306424
Contact name
Frank McDermott
Contact email
Sponsor organisation
Origin Sciences Ltd
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
This is a Feasibility Study to Investigate the Genomic and Epigenetic Changes within Rectal Mucus in Non-colorectal Cancers of the Aero-digestive Tract. 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).
Participants with confirmed non-small cell lung cancer (NSCLC), oesophageal, gastric and duodenal cancer, pancreatic cancer, biliary tract cancer (BTC) who have received a diagnosis but not commenced treatment at the time of participation will be eligible to participate. 50 participants with be enrolled into the study, each of the following cancer types: NSCLC, oesophagogastric, pancreatic, BTC, urothelial along with 50 control participants with no known malignancy and a complete negative colonoscopy taken from a biobank from previous studies. Participants will also be asked to provide a blood sample, an oral mucus swab and a stool sample.REC name
Wales REC 6
REC reference
21/WA/0400
Date of REC Opinion
17 Dec 2021
REC opinion
Favourable Opinion