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Recruiting NCT05102110

Feasibility Study to Investigate Rectal Mucus in Aero-Digestive Tract Cancer.

Trial Parameters

Condition Non Small Cell Lung Cancer
Sponsor Origin Sciences
Study Type OBSERVATIONAL
Phase N/A
Enrollment 450
Sex ALL
Min Age 18 Years
Max Age 99 Years
Start Date 2021-12-01
Completion 2027-07-30
Interventions
Oricol Test

Brief 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 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.

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