Oesophageal cancer Cancer
Conditions
Interventions
Medical history
• To confirm eligibility
• Location of primary tumour
• Histological and molecular diagnosis details – Human epidermal growth factor receptor 2 (HER2), PD-L1 testing
• Tumour stage acc
OR
o After the completion of the latest line of anticancer treatment*
OR
o During follow up when a participant is not receiving or is between scheduled anti-cancer treatments*.
*Anti-cancer treatments excluding surgery
• The biopsy may be obtained from any site of tumou
Sponsors
University of Dundee
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 18 years of age or older 2. Willing and able to provide written informed consent 3. Histologically confirmed oesophageal or gastroesophageal junctional adenocarcinoma. 4. Able to provide a tumour biopsy sample as per protocol requirements
Exclusion criteria
Exclusion criteria: 1. Concurrent systemic anti-cancer treatment and/or radiotherapy (participants undergoing cancer surgery are eligible.) 2. Any significant medical condition that in the opinion of the Principal Investigator (PI) would impair the ability of the participant to complete the requirements of the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neoantigen profiles for individual patients with oesophageal or gastroesophageal junction adenocarcinomas measured by liquid chromatography-tandem mass spectrometry (LC-MS/MS) of tumour biopsies taken at Day 1 and a maximum of 3 further optional research biopsy samples may be collected between day 1 and week 18, timings will vary for participants for these biopsies to fit in with their standard care procedures. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of patients in which neoantigen profiles are successfully generated measured as percent of patients in the study for whom neoantigen profiles are obtained by liquid chromatography-tandem mass spectrometry (LC-MS/MS) of their tumour biopsies taken at Day 1 and a maximum of 3 further optional research biopsy samples may be collected between day 1 and week 18, timings will vary for participants for these biopsies to fit in with their standard care procedures. 2. Characterise pre-existing T cell responses to identified neoantigens measured by ex vivo IFN Gamma ELISPOT assays on peripheral blood mononuclear cells isolated from patients stimulated with synthesized neoepitope peptides identified from patient's tumour biopsies 3. Correlate objective response rate, disease control rate, progression free survival and overall survival with neoantigen profiles measured by analysis of participants grouped by any identified common features of neoantigen profiles of tumours 4. Genomic and transcriptomic analysis and neoantigen validation measured by Whole genome sequencing and RNA sequencing of tumour biopsies and compared to neoantigen profiles of individual patients with oesophageal or gastroesophageal junction adenocarcinomas measured by liquid chromatography-tandem mass spectrometry (LC-MS/MS) of tumour biopsies | — |
Countries
England, Northern Ireland, Scotland, United Kingdom, Wales
Contacts
Public ContactMargaret Band
Outcome results
None listed