What is TransRAMPART?
TransRAMPART is a translational research study being run within the RAMPART clinical trial. The study involves the collection of several different sample types (blood, urine and tumour tissue) throughout RAMPART participant treatment and follow-up for future research.
Why are we running this study?
We know that people even with the same type of cancer respond differently to treatment and experience different levels of side effects. It is important to try to understand how a person’s genetic make-up influences how they will respond.
TransRAMPART will provide a unique opportunity to address which RCC patients are most in need of adjuvant treatment with immune checkpoint inhibitors; predict those patients who will respond to these agents, identify when and how resistance may develop and pre-empt patients who will experience significant toxicity.
To date a number of biomarkers, including PD-L1 expression and tumour mutational burden, have emerged as predictors of benefit from immune checkpoint blockade in other solid tumour types. Given the size of the TransRAMPART cohort and the comprehensive sampling of tumours we would like to carry out, we are in a unique position to identify biomarkers of response, which could ultimately serve both adjuvant and metastatic RCC populations, as well as to identify recurrent mechanisms of resistance and immune-related adverse events.
What samples are being collected in TransRAMPART?
All patients that are participating in the RAMPART study will be providing a blood sample, as well as a sample of their cancer that was removed during surgery. TransRAMPART is an expanded sample collection, building on the samples already obtained through RAMPART and supplementing them with additional sample types and collection time points. These samples will be collected at visits patients are attending as part of their RAMPART follow-up, so no additional visits will be required.
To ensure that all sites can contribute to the study, we have defined 3 participation levels (Bronze, Silver and Gold) which increase in complexity. All RAMPART sites are effectively already participating at the Bronze level (single blood samples on recruitment to RAMPART), but with the support of our Investigators we hope that most will commit to collecting additional samples that will enable us to expand our research. Participating at the Silver level involves relatively little extra effort (longitudinal blood sampling using preservative based tubes, hence no processing needed at site) and we hope that our ECMC sites will be up to the challenge of participating at the Gold level, which is slightly more involved with some of the samples requiring on-site processing. Please refer to the table below for full details of the samples being collected at each participation level.
All samples collected as part of TransRAMPART will be sent to our central lab at Cambridge University where they will be processed and stored for future use.
Where is the study being conducted?
The TransRAMPART study is being run at all participating RAMPART sites in the UK. The level of participation at each site will depend on the local resources and infrastructure. Please refer to the Site Map for details of the sites that are currently participating at each level. If your site is interested in participating please contact the RAMPART team to discuss this further.
For full details of the TransRAMPART study, please refer to the TransRAMPART Protocol.