Adenocarcinoma EsophagusMAGnETNCT06702384
Molecular Analysis of Gastric and OEsophageal Cancers STudy
An observational study of Adenocarcinoma Esophagus and Adenocarcinoma of the Stomach, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
A prospective translational tissue collection study to identify biomarkers predictive of treatment response/resistance and biomarkers of prognostic value from a series of patients who are investigated for and diagnosed with early or advanced gastric/junctional or oesophageal cancer (oesophagogastric cancer) at The… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Adenocarcinoma Esophagus, Adenocarcinoma of the Stomach, Adenocarcinoma - GEJ
- What is being tested?
- biopsy
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2025to May 2030
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergoing endoscopy or surgery for OGC (adenocarcinoma or squamous cell carcinoma) or patients who have recently with been diagnosed with OGC and are due to start treatment. Patients will be recruited from The Royal Marsden NHS Foundation Trust. Patients will need to have sufficient tissue to be available for analysis.
Who may be able to join
- Patient is being investigated/treated for OGC at The Royal Marsden Hospital during the study period.
- Patient has an oesophageal/gastric mass or metastasis amenable to core needle biopsy or surgery.
- Patient is clinically fit enough to undergo a tumour biopsy or surgery (if not already performed) according to investigator assessment and local guidelines.
- Patient is ≥ 18 years of age.
- Patient is able to understand the information provided within the patient information sheet and is able to provide written informed consent.
- Patient has sufficient tissue for analysis.
Who cannot join
- Patients who are not treated at The Royal Marsden Hospital or referring centre.
- Patients who have a second active malignancy other than oesophageal/gastric cancer.
- Patients who have one or more contraindications to a tumour biopsy or surgery (if not already performed) according to local guidelines.
- Patients with an uncontrolled concomitant medical condition including, but not limited to, ongoing or active infection not amenable to standard antibiotic therapy, irreversible increased risk of bleeding which prevents biopsy as per standard procedures, or a psychiatric illness or social situation that could affect compliance with study procedures.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Marsden NHS Foundation Trust - London
London, SW3 6JJ
About this study
Official title: A Prospective Translational Tissue Collection Study in Early and Advanced Gastric and Oesophageal Cancers to Enable Further Disease Characterisation and the Development of Potential Predictive and Prognostic Biomarkers
A prospective translational tissue collection study to identify biomarkers predictive of treatment response/resistance and biomarkers of prognostic value from a series of patients who are investigated for and diagnosed with early or advanced gastric/junctional or oesophageal cancer (oesophagogastric cancer) at The Royal Marsden Hospital.
Read the detailed description
Tissue samples and biological specimens (which may include blood, stool, saliva) from patients with a suspected/confirmed oesophagogastric cancer (OGC) at The Royal Marsden NHS Foundation Trust over the study period will be collected and stored on behalf of The Royal Marsden NHS Foundation Trust. Molecular analyses including, but not limited to, miRNA analysis, DNA and RNA sequencing, nanostring, RT-PCR and immunohistochemistry will be carried out. Stool and saliva samples may be analysed to assess the microbiota present. Molecular analyses data and microbiota data will be collated in a link-anonymised manner and correlated to clinical outcome data.
This prospective study is intended to set up a database of patients treated both for oesophageal cancer and gastric cancer with availability of annotated clinical data and tumour tissue plus biological specimens. This series will serve as a valuable platform to analyse the expression of several biomarkers of potential interest. There will also be the opportunity to assess the prognostic and predictive role of identified biomarkers in specific patient subgroups and in relation to specific treatments. Within this study, we may also hope to develop organoid and patient derived xenograft models to represent locally advanced and metastatic disease which will support future drug development. We aim to also investigate the microbiome of patients diagnosed with OGC. In addition, this database can serve as a validation cohort for the external validation of findings from other projects in OGC which are of clinical relevance. The molecular analysis plans for the study will develop as the study progresses and as new data emerges which will generate new hypotheses to investigate.
- Conditions
- Adenocarcinoma Esophagus, Adenocarcinoma of the Stomach, Adenocarcinoma - GEJ, Squamous Cell Car. - Esophagus
- Being tested
- biopsy
- Medical subject headings
- Adenocarcinoma Of Esophagus, Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biopsyDiagnostic test
Baseline biopsy and biological specimens
| Study group | Role | What they receive |
|---|---|---|
| early stage curative disease | Not described Receives: Diagnostic Test: biopsy | |
| Locally advanced or metastatic disease | Not described Receives: Diagnostic Test: biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence and distribution of biomarkers potentially prognostic or predictive of treatment response/resistance in a large series of patients with OGC
Measured: 5 years
Secondary outcomes (5)
Disease control rate (CR, PR and SD) in locally advanced/metastatic disease
Measured: 5 years
Duration of response (CR/PR) in locally advanced/metastatic disease
Measured: 5 years
Progression free survival (PFS) in locally advanced/metastatic disease
Measured: 5 years
Relapse free survival (RFS) in early stage curative disease
Measured: 5 years
Overall Survival (OS) according to stage of disease
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study startAug 2025 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionMay 2030 (estimated)
Why it stopped: Never opened to recruitment due to lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma EsophagusStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Avani Athauda, Principal investigator, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06702384
- Sponsor's protocol ID
- CCR 5139
- Other IDs
- 20/LO/0506, 264017
- Acronym
- MAGnET
- Status last verified
- Sep 2024
- First submitted
- 24 Feb 2022
- Last updated
- 6 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Translational Tissue Collection Study in Early and Advanced Gastric and Oesophageal Cancers to Enable Further Disease Characterisation and the Development of Potential Predictive and Prognostic Biomarkers
- ClinicalTrials.gov ID
- NCT06702384
- Acronym / sponsor ID
- MAGnET / CCR 5139
- Conditions
- Adenocarcinoma Esophagus, Adenocarcinoma of the Stomach, Adenocarcinoma - GEJ, Squamous Cell Car. - Esophagus
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Never opened to recruitment due to lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Study start
- Aug 2025 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 25 Nov 2024 (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.
A prospective translational tissue collection study to identify biomarkers predictive of treatment response/resistance and biomarkers of prognostic value from a series of patients who are investigated for and diagnosed with early or advanced gastric/junctional or oesophageal cancer (oesophagogastric cancer) at The Royal Marsden Hospital.
Detailed description
Tissue samples and biological specimens (which may include blood, stool, saliva) from patients with a suspected/confirmed oesophagogastric cancer (OGC) at The Royal Marsden NHS Foundation Trust over the study period will be collected and stored on behalf of The Royal Marsden NHS Foundation Trust. Molecular analyses including, but not limited to, miRNA analysis, DNA and RNA sequencing, nanostring, RT-PCR and immunohistochemistry will be carried out. Stool and saliva samples may be analysed to assess the microbiota present. Molecular analyses data and microbiota data will be collated in a link-anonymised manner and correlated to clinical outcome data.
This prospective study is intended to set up a database of patients treated both for oesophageal cancer and gastric cancer with availability of annotated clinical data and tumour tissue plus biological specimens. This series will serve as a valuable platform to analyse the expression of several biomarkers of potential interest. There will also be the opportunity to assess the prognostic and predictive role of identified biomarkers in specific patient subgroups and in relation to specific treatments. Within this study, we may also hope to develop organoid and patient derived xenograft models to represent locally advanced and metastatic disease which will support future drug development. We aim to also investigate the microbiome of patients diagnosed with OGC. In addition, this database can serve as a validation cohort for the external validation of findings from other projects in OGC which are of clinical relevance. The molecular analysis plans for the study will develop as the study progresses and as new data emerges which will generate new hypotheses to investigate.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| early stage curative disease | – | Diagnostic Test: biopsy |
| Locally advanced or metastatic disease | – | Diagnostic Test: biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing endoscopy or surgery for OGC (adenocarcinoma or squamous cell carcinoma) or patients who have recently with been diagnosed with OGC and are due to start treatment. Patients will be recruited from The Royal Marsden NHS Foundation Trust. Patients will need to have sufficient tissue to be available for analysis.
Key inclusion criteria (6 listed)
- Patient is being investigated/treated for OGC at The Royal Marsden Hospital during the study period.
- Patient has an oesophageal/gastric mass or metastasis amenable to core needle biopsy or surgery.
- Patient is clinically fit enough to undergo a tumour biopsy or surgery (if not already performed) according to investigator assessment and local guidelines.
- Patient is ≥ 18 years of age.
- Patient is able to understand the information provided within the patient information sheet and is able to provide written informed consent.
Key exclusion criteria (4 listed)
- Patients who are not treated at The Royal Marsden Hospital or referring centre.
- Patients who have a second active malignancy other than oesophageal/gastric cancer.
- Patients who have one or more contraindications to a tumour biopsy or surgery (if not already performed) according to local guidelines.
- Patients with an uncontrolled concomitant medical condition including, but not limited to, ongoing or active infection not amenable to standard antibiotic therapy, irreversible increased risk of bleeding which prevents biopsy as per standard procedures, or a psychiatric illness or social situation that could affect compliance with study procedures.
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 |
|---|---|---|
| biopsyBaseline biopsy and biological specimens | Diagnostic test | Locally advanced or metastatic disease, early stage curative disease |
Primary outcome
The prevalence and distribution of biomarkers potentially prognostic or predictive of treatment response/resistance in a large series of patients with OGC
Time frame: 5 years
5 secondary outcomes
Disease control rate (CR, PR and SD) in locally advanced/metastatic disease
Time frame: 5 years
Duration of response (CR/PR) in locally advanced/metastatic disease
Time frame: 5 years
Progression free survival (PFS) in locally advanced/metastatic disease
Time frame: 5 years
Relapse free survival (RFS) in early stage curative disease
Time frame: 5 years
Overall Survival (OS) according to stage of disease
Time frame: 5 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Dr Avani Athauda principal investigator
Royal Marsden NHS Foundation Trust
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 Adenocarcinoma Esophagus and Adenocarcinoma of the Stomach, run by Royal Marsden NHS Foundation Trust 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 6 inclusion and 4 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: withdrawn, as of the sponsor's last update on 6 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
The prevalence and distribution of biomarkers potentially prognostic or predictive of treatment response/resistance in a large series of patients with OGC (time frame: 5 years). 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 6 Feb 2025.