VISION: TNBC sample and clinical data acquisition study
Research type
Research Study
Full title
The VISION Project: Defining biomarkers of chemotherapy and immunotherapy response, and validation of the Breast cancer therapeutic response predictive algorithm for early Triple Negative Breast Cancers (TNBC).
IRAS ID
322036
Contact name
Uzma Asghar
Contact email
Sponsor organisation
Concr LTD
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
This is a retrospective observational research study designed to extract historical clinical data and archival breast cancer samples from women previously diagnosed with early triple negative breast cancer (stage 2 or stage 3) and, previously treated with neoadjuvant chemotherapy +/- immunotherapy followed by curative breast surgery. This study will run over a one year period and is commercially funded by the tech bio company Concr LTD.
The two study arms include:
Arm A (n=100): Women who experienced complete disappearance of their breast cancer following neoadjuvant chemotherapy +/- immunotherapy (pathological complete response)
Arm B (n=100): Women with persistent breast cancer following neoadjuvant chemotherapy +/- immunotherapy (residual disease).
The aims of this study are to use the clinical information and the tumour sequencing data in order to:
1. Identify biomarkers of response to chemotherapy and immunotherapy
2. Validate a new computer programme which is able to predict drug responses in women before starting treatment.Relevant clinical data will be extracted for each individual. Relevant clinical information includes a patient's age, menopausal status, ethnicity, cancer stage, treatment given, response to treatment, if the individual experienced a further breast cancer cancer relapse and survival status i.e. are they alive or have they died.
The archival (old) breast cancer tissue samples will be collected from two time points:
1. Before starting neoadjuvant chemotherapy
2. After completion of neoadjuvant chemotherapy, taken at the time of breast surgery.Women do not need to have extra research biopsies for this study.
The breast cancer samples will be undergo gene testing using next generation technologies provided by commercial companies.
We hope to recruit 200 women with at least 2 years of follow up mainly from NHS sites in the UK and some from Australia.
REC name
London - Chelsea Research Ethics Committee
REC reference
23/PR/0077
Date of REC Opinion
4 Apr 2023
REC opinion
Further Information Favourable Opinion