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

NCT05102110 | Recruiting

• 1 other identifier: ORICOL-EGI-03
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Small Cell Lung Cancer; Pancreatic Cancer; Bladder Cancer; Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Correlation of SNP allele frequency in genes associated with known aero-digestive cancers in paired samples of tumour type and rectal mucus.

  Genomic analysis

  1 year

Study Arms (4)

Non-small cell lung cancer

A cohort of patients with known NSCLC who are assessed.

Diagnostic Test: Oricol Test

Pancreatic cancer

A cohort of patients with known pancreatic adenocarcinoma who are assessed.

Diagnostic Test: Oricol Test

Urothelial cancers

A cohort of patients with known uroepithelial cancers who are assessed.

Diagnostic Test: Oricol Test

Colorectal cacncers

A cohort of patients with known colorectal cancers have been added to the study following methodology change in analysis techniques.

Interventions

Oricol Test DIAGNOSTIC_TEST

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

Non-small cell lung cancer; Pancreatic cancer; Urothelial cancers

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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. Control population will be participants with confirmed Urothelial Cancers who have received a diagnosis but not commenced treatment at the time of participation and participants with no known malignant pathology who have undergone a negative colonoscopy.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Origin Sciences: lead
• Royal Devon and Exeter NHS Foundation Trust: collaborator
• Norfolk and Norwich University Hospitals NHS Foundation Trust: collaborator
• The Leeds Teaching Hospitals NHS Trust: collaborator

Study Sites (1)

Royal Devon & Exeter NHS Foundation Trust

Exeter, EX2 4UG, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Rectal mucus collection with fragments of genetic material retrieved from rectal mucus.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Pancreatic Neoplasms; Urinary Bladder Neoplasms; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Mr F McDermott, FRCS

  Chief Investigator

  STUDY DIRECTOR

Central Study Contacts

Ian Daniels, FRCS

CONTACT

01223 750490; Ian.Daniels@originsciences.com

Hugo Lywood

CONTACT

01223750490; hugo.lywood@originsciences.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2021
• First Posted: November 1, 2021
• Study Start: December 1, 2021
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

GB (1)