Trials / Withdrawn
WithdrawnNCT06702384
Molecular Analysis of Gastric and OEsophageal Cancers STudy
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
- Status
- Withdrawn
- Phase
- —
- Study type
- Observational
- Enrollment
- 0 (actual)
- Sponsor
- Royal Marsden NHS Foundation Trust · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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 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.
Conditions
- Adenocarcinoma Esophagus
- Adenocarcinoma of the Stomach
- Adenocarcinoma - GEJ
- Squamous Cell Car. - Esophagus
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | biopsy | Baseline biopsy and biological specimens |
Timeline
- Start date
- 2025-08-01
- Primary completion
- 2027-05-01
- Completion
- 2030-05-01
- First posted
- 2024-11-25
- Last updated
- 2025-02-06
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT06702384. Inclusion in this directory is not an endorsement.