Molecular Analysis of Gastric and OEsophageal Cancers STudy
NCT ID: NCT06702384
Last Updated: 2025-02-06
Study Results
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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WITHDRAWN
OBSERVATIONAL
2025-08-31
2030-05-31
Brief Summary
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Detailed Description
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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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Study Design
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COHORT
PROSPECTIVE
Study Groups
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early stage curative disease
biopsy
Baseline biopsy and biological specimens
Locally advanced or metastatic disease
biopsy
Baseline biopsy and biological specimens
Interventions
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biopsy
Baseline biopsy and biological specimens
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
Yes
Sponsors
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Royal Marsden NHS Foundation Trust
OTHER
Responsible Party
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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
Countries
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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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