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

NCT05102110 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 450

Last updated 2026-03-16

No results posted yet for this study

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.

Conditions

Interventions

DIAGNOSTIC_TEST

Oricol Test

Assessment of rectal mucus for material from aero-digestive cancers.

Sponsors & Collaborators

  • Royal Devon and Exeter NHS Foundation Trust

    collaborator OTHER
  • Norfolk and Norwich University Hospitals NHS Foundation Trust

    collaborator OTHER
  • The Leeds Teaching Hospitals NHS Trust

    collaborator OTHER
  • Origin Sciences

    lead INDUSTRY

Principal Investigators

  • Mr F McDermott, FRCS · Chief Investigator

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2027-07-30
Completion
2027-12-01

Countries

  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05102110 on ClinicalTrials.gov