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Enrolling by Invitation

NCT Number: NCT06820151

Exploring the Landscape of Injury and Repair in the Human Oesophagus

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.

Enrolling by Invitation

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Wellcome Sanger Institute

Cambridge, United Kingdom

About this study

Tissue injury activates a number of cellular responses to initiate wound healing, resulting in the formation of new tissue within a short span of time and in a controlled fashion. In contrast, cancer results when a tissue mass forms in an unregulated process. Understanding the molecular mechanisms behind appropriate wound healing enables us to delineate how this process goes askew in the context of cancer. The goal 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 this study, the researchers wish to recruit adult patients undergoing endoluminal vacuum therapy (EVT therapy) 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. The researchers will request consent for access to archived tissue samples from any previous related surgery and some associated clinical metadata. The samples and associated clinical metadata will then be pseudonymised and sent to the Wellcome Sanger Institute.

Once samples are received at the Wellcome Sanger Institute, they will undergo a number of procedures including but not limited to genome sequencing, this will enable the researchers to gain a better understanding of the wound healing process, specifically how it can sometimes go wrong and lead to the development of cancer.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Sample collection

Other

Sample collection: EVT sponges, tissue brushings and pinch biopsies

Primary outcomes

  1. Genetic changes in regenerating oesophageal tissue

    Time frame: approximately 52 months

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

  2. Characterising germline mutations

    Time frame: approximately 52 months

    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)

  3. DNA sequencing

    Time frame: approximately 52 months

    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.

Sponsors and collaborators

Lead sponsor

The Wellcome Sanger Institute

Other

Registry information

Official study title

Characterising the Genomic and Phenotypic Changes That Define Injury and Repair in the Context of Early Carcinogenesis in the Human Oesophagus.

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Feb 11, 2025
Registry last updated
Feb 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.