RecruitingNCT05102110

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

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

Sponsor

Origin Sciences

Enrollment

450 participants

Start Date

Dec 1, 2021

Study Type

OBSERVATIONAL

Conditions

Colorectal, Cancer Pancreatic Cancer Non-small Cell Lung Cancer Bladder Cancer

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

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This is a feasibility study exploring whether rectal mucus — collected via a simple, non-invasive procedure — can be used to detect early signs of cancer in the digestive and airway tract, potentially offering a less invasive alternative to standard biopsies. **You may be eligible if...** - You are 18 years or older - You are able to give voluntary written consent **You may NOT be eligible if...** - You have conditions that would make the rectal collection procedure unsafe, such as an acute anal fissure, severely painful hemorrhoids, or obstructing rectal lesions - You have a previous history of cancer - You have received radiotherapy, chemotherapy, or immunotherapy for cancer in the past Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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