Exploring the Landscape of Injury and Repair in the Human Oesophagus

NCT06820151 | Enrolling By Invitation

• 1 other identifier: 293952
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study limited to working with human tissue samples is to delineate the mechanisms defining appropriate oesophageal injury and repair and to use this information to understand how these rules are dysregulated and result in cancer formation in adult patients undergoing endoluminal vacuum therapy (EVT therapy) for the treatment of perforations to the oesophagus. The main question\[s\] it aims to answer are:

• to gain a deeper understanding of the processes underlying tissue regeneration and repair in the oesophagus and upper gastro-intestinal tract following physical injury
• to identify the similarities in the processes of regeneration and early carcinogenesis Participants will take part in the study during their usual EVT therapy schedule. Tissue brushings and pinch biopsies will also be taken.

Conditions

Perforations to the Oesophagus

Outcome Measures

Primary Outcomes (3)

• Genetic changes in regenerating oesophageal tissue

  To develop a detailed description of the genetic changes in regenerating oesophageal tissue in cancerous vs. non-cancerous oesophageal tissue

  approximately 52 months

• Characterising germline mutations

  blood samples will be used to characterise the 'germline mutations' or inherited mutations present in all of the participants cells. The samples will be processed to separate the white blood cells which will then undergo processes to look at individual genes, collections of genes, exomes, whole exomes and whole genome sequencing (WGS)

  approximately 52 months

• DNA sequencing

  DNA from microdissected and in vitro cultured tissues will be extracted and sequenced using state-of-the-art sequencing methods to look at individual genes, collections of genes, exomes, whole exomes and whole genomes.

  approximately 52 months

Study Arms (2)

Group 1

Group 1 will include patients who are having elective upper gastro-intestinal surgery where a leak is a recognised complication (but has not occurred).

Other: Sample collection

Group 2

Group 2 will include patients who present acutely with an upper gastro-intestinal leak.

Other: Sample collection

Interventions

Sample collection OTHER

Sample collection: EVT sponges, tissue brushings and pinch biopsies

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing endoluminal vacuum therapy (EVT) for the treatment of perforations to the oesophagus in order to collect the discarded EVT sponge, biopsies from endoscopies, resected surgical specimens and additional blood samples.

You may qualify if:

• Male and Female patients 18 years old and over who are having elective upper gastro-intestinal surgery where a leak is a recognised complication (but has not occurred)
• Male and Female patients 18 years and over who present acutely with an upper gastro-intestinal leak.

You may not qualify if:

• patients who do not have a good understanding of the English Language

Sponsors & Collaborators

• The Wellcome Sanger Institute: lead

Study Sites (1)

Wellcome Sanger Institute

Cambridge, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

EVT sponges, tissue brushings and pinch biopsies from upper GI surgery

MeSH Terms

Interventions

Specimen Handling

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• AYESHA NOORANI, PhD MRCS

  Genome Research Limited operating as The Wellcome Sanger Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: February 11, 2025
• Study Start: March 1, 2022
• Primary Completion: April 29, 2026
• Study Completion: April 29, 2026
• Last Updated: February 11, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)