Perforations to the OesophagusNCT06820151
Exploring the Landscape of Injury and Repair in the Human Oesophagus
An observational study of Perforations to the Oesophagus, run by The Wellcome Sanger Institute at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Perforations to the Oesophagus
- What is being tested?
- Sample collection
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2022to 29 Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- patients who do not have a good understanding of the English Language
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Characterising the Genomic and Phenotypic Changes That Define Injury and Repair in the Context of Early Carcinogenesis 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:
Read more
- 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.
Read the 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.
- Conditions
- Perforations to the Oesophagus
- Being tested
- Sample collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sample collectionOther
Sample collection: EVT sponges, tissue brushings and pinch biopsies
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Sample collection | |
| Group 2 | Group 2 will include patients who present acutely with an upper gastro-intestinal leak. Receives: Other: Sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 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.
Measured: approximately 52 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start1 Mar 2022
- Primary completion29 Apr 2026 (estimated)
- Study completion29 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perforations to the OesophagusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Wellcome Sanger Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- AYESHA NOORANI, PhD MRCS, Principal investigator, Genome Research Limited operating as The Wellcome Sanger Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06820151
- Sponsor's protocol ID
- 293952
- Status last verified
- Jan 2025
- First submitted
- 29 Jan 2025
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The Wellcome Sanger Institute never shares identifiable information about any of those who participate in its research and has strict measures in place to ensure that the privacy of research participants is protected.
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterising the Genomic and Phenotypic Changes That Define Injury and Repair in the Context of Early Carcinogenesis in the Human Oesophagus.
- ClinicalTrials.gov ID
- NCT06820151
- Acronym / sponsor ID
- 293952
- Conditions
- Perforations to the Oesophagus
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The Wellcome Sanger InstituteUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 29 Apr 2026 (estimated)
- Study completion
- 29 Apr 2026 (estimated)
- First posted
- 11 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: Sample collectionGroup 1 will include patients who are having elective upper gastro-intestinal surgery where a leak is a recognised complication (but has not occurred). |
| Group 2 | – | Other: Sample collectionGroup 2 will include patients who present acutely with an upper gastro-intestinal leak. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- patients who do not have a good understanding of the English Language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sample collectionSample collection: EVT sponges, tissue brushings and pinch biopsies | Other | Group 1, Group 2 |
Primary outcome
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
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)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
- Individual participant dataSharing planned: No. The Wellcome Sanger Institute never shares identifiable information about any of those who participate in its research and has strict measures in place to ensure that the privacy of research participants is protected.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
AYESHA NOORANI, PhD MRCS principal investigator
Genome Research Limited operating as The Wellcome Sanger Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perforations to the Oesophagus, run by The Wellcome Sanger Institute at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genetic changes in regenerating oesophageal tissue (time frame: approximately 52 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2025.