Molecular Analysis of Gastric and OEsophageal Cancers STudy

NCT ID: NCT06702384

Last Updated: 2025-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-31

Study Completion Date

2030-05-31

Brief Summary

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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

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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

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Adenocarcinoma Esophagus Adenocarcinoma of the Stomach Adenocarcinoma - GEJ Squamous Cell Car. - Esophagus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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early stage curative disease

biopsy

Intervention Type DIAGNOSTIC_TEST

Baseline biopsy and biological specimens

Locally advanced or metastatic disease

biopsy

Intervention Type DIAGNOSTIC_TEST

Baseline biopsy and biological specimens

Interventions

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biopsy

Baseline biopsy and biological specimens

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. Patient is being investigated/treated for OGC at The Royal Marsden Hospital during the study period.
2. Patient has an oesophageal/gastric mass or metastasis amenable to core needle biopsy or surgery.
3. Patient is clinically fit enough to undergo a tumour biopsy or surgery (if not already performed) according to investigator assessment and local guidelines.
4. Patient is ≥ 18 years of age.
5. Patient is able to understand the information provided within the patient information sheet and is able to provide written informed consent.
6. Patient has sufficient tissue for analysis.

Exclusion Criteria

1. Patients who are not treated at The Royal Marsden Hospital or referring centre.
2. Patients who have a second active malignancy other than oesophageal/gastric cancer.
3. Patients who have one or more contraindications to a tumour biopsy or surgery (if not already performed) according to local guidelines.
4. 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Royal Marsden NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dr Avani Athauda

Role: PRINCIPAL_INVESTIGATOR

Royal Marsden NHS Foundation Trust

Locations

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Royal Marsden NHS Foundation Trust - London

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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20/LO/0506

Identifier Type: OTHER

Identifier Source: secondary_id

264017

Identifier Type: OTHER

Identifier Source: secondary_id

CCR 5139

Identifier Type: -

Identifier Source: org_study_id

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