Molecular Analysis of Gastric and OEsophageal Cancers STudy

NCT06702384 | Withdrawn

• 3 other identifiers: CCR 513920/LO/0506264017
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• The prevalence and distribution of biomarkers potentially prognostic or predictive of treatment response/resistance in a large series of patients with OGC

  5 years

Secondary Outcomes (5)

• Disease control rate (CR, PR and SD) in locally advanced/metastatic disease

  5 years

• Duration of response (CR/PR) in locally advanced/metastatic disease

  5 years

• Progression free survival (PFS) in locally advanced/metastatic disease

  5 years

• Relapse free survival (RFS) in early stage curative disease

  5 years

• Overall Survival (OS) according to stage of disease

  5 years

Study Arms (2)

early stage curative disease

Diagnostic Test: biopsy

Locally advanced or metastatic disease

Diagnostic Test: biopsy

Interventions

biopsy DIAGNOSTIC_TEST

Baseline biopsy and biological specimens

Locally advanced or metastatic disease; early stage curative disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead

Study Sites (1)

Royal Marsden NHS Foundation Trust - London

London, SW3 6JJ, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Baseline tumour biopsy, biopsy at progression. Research blood, saliva stool as appropriate.

MeSH Terms

Conditions

Adenocarcinoma Of Esophagus; Esophageal Squamous Cell Carcinoma

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Dr Avani Athauda

  Royal Marsden NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2022
• First Posted: November 25, 2024
• Study Start: August 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2030
• Last Updated: February 6, 2025

Record last verified: 2024-09

Locations

GB (1)