Advanced HER2 positive gastroesophageal adenocarcinoma Cancer Malignant neoplasm of oesophagus, malignant neoplasm of stomach
Conditions
Interventions
Blood samples will be collected from participants at the start of the chemotherapy + trastuzumab therapy and will be analysed by NGS to capture the molecular mechanisms involved in trastuzumab resista
Sponsors
University of Dundee
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or older 2. Willing to provide written informed consent 3. Diagnosed with histologically confirmed locally advanced or metastatic HER2 positive gastroesophageal adenocarcinoma 4. Subject is being considered for treatment with the standard of care platinum fluoropyrimidine combination chemotherapy plus trastuzumab therapy and is willing and able to proceed with this treatment 5. Subject is able to provide whole blood at baseline visit and final visit
Exclusion criteria
Exclusion criteria: 1. Any medical or mental condition that would interfere with the subject’s ability to willingly give written informed consent 2. Any significant medical condition that in the opinion of the chief investigator would impair the ability of the participant to complete the requirements of the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Detection at relapse of molecular abnormalities related to trastuzumab resistance by ctDNA profiling of biopsy taken at a single time point | — |
Secondary
| Measure | Time frame |
|---|---|
| Using biopsy taken at a single time point: 1. Detection of molecular abnormalities using liquid biopsy 2. Detection of molecular abnormalities using the standard of care tissue biopsy analysis 2. Identification of new or known resistance-related gene variants using next generation sequencing-based ctDNA profiling and definition of a correlation between the genotype of the primary tumour and the emergence of molecularly different clones | — |
Countries
United Kingdom
Contacts
Public ContactRussell Petty
Outcome results
None listed