Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2026-01-03 @ 12:25 AM
Study NCT ID:
NCT06820151
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-02-11
First Post:
2025-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exploring the Landscape of Injury and Repair in the Human Oesophagus
Sponsor:
The Wellcome Sanger Institute
Organization:
Study Overview
Official Title:
Characterising the Genomic and Phenotypic Changes That Define Injury and Repair in the Context of Early Carcinogenesis in the Human Oesophagus.
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: