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Feasibility Study to Investigate the Genomic and Epigenetic Changes in Rectal Mucus in Non-Colorectal Cancers of the Aero-Digestive Tract (ORI-EGI-03).

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• Aged 18 years or over Be able to give voluntary, written informed consent to participate in the study

Locations
Other Locations
United Kingdom
Royal Devon & Exeter NHS Foundation Trust
RECRUITING
Exeter
Contact Information
Primary
Ian Daniels, FRCS
Ian.Daniels@originsciences.com
01223 750490
Backup
Hugo Lywood
hugo.lywood@originsciences.com
01223750490
Time Frame
Start Date: 2021-12-01
Estimated Completion Date: 2027-12-01
Participants
Target number of participants: 450
Treatments
Non-small cell lung cancer
A cohort of patients with known NSCLC who are assessed.
Pancreatic cancer
A cohort of patients with known pancreatic adenocarcinoma who are assessed.
Urothelial cancers
A cohort of patients with known uroepithelial cancers who are assessed.
Colorectal cacncers
A cohort of patients with known colorectal cancers have been added to the study following methodology change in analysis techniques.
Sponsors
Collaborators: Norfolk and Norwich University Hospitals NHS Foundation Trust, Royal Devon and Exeter NHS Foundation Trust, The Leeds Teaching Hospitals NHS Trust
Leads: Origin Sciences

This content was sourced from clinicaltrials.gov

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