Translational Studies and Projects
Translational research (TR) studies, which aim at developing, testing, and validating new biomarkers, tumor signatures or assays, are increasingly gaining significance within modern oncology. These studies are often the basis for novel diagnostic tools and thereby for targeted and personalized therapies, which are becoming more common in clinical trials and daily clinical practice. ABCSG is involved in – and operationally conducts – numerous translational research projects and collaborations as the extensive collection of biosamples and data from former ABCSG trials is a valuable resource for such projects.
The TraX&Vields project in collaboration with Cepheid is one of ABCSG’s largest endeavors, as it includes work packages for multiple former ABCSG trial patient cohorts. The main aim of all work packages is twofold: the Cepheid GeneXpert Breast Cancer STRAT4 is a novel test to reliably, reproducibly, and quantitatively test common tumor markers using their mRNA expression levels. This test is to be validated in a number of ABCSG trial patient cohorts and has already achieved CE-certification in some countries. Secondly, a prognostic breast cancer signature to predict the recurrence risk of early breast cancer patients is to be developed and validated. In 2020, a new predictive breast cancer signature (Xpert Insight) has come into focus and is planned to be validated in various ABCSG cohorts as well.
Work is continuing on a number of Cepheid work packages in parallel: for the Trax&Vields-05 project (ABCSG-34 cohort), clinical follow-up data was collected from former ABCSG-34 trial patients. This data will be used to validate a prognostic breast cancer signature and for further explorative analysis of the STRAT4 test. All laboratory work on available tumor samples stored from this cohort in the ABCSG central research facility was completed and the validation of STRAT4 concordance data is already complete as well. Data analysis using the extended clinical follow-up data will be the final step in this cohort.
Great progress was made in the TraX&Vields-02 work package (ABCSG-8): after receiving full approval, the laboratory work was started in summer 2022.
In the work packages concerning the ABCSG-12 cohort, former ABCSG-12 sites are involved in collecting clinical follow-up data of ABCSG-12 patients and in centralizing tumor samples of these patients in the ABCSG central research facility in Vienna. Laboratory analysis of centralized ABCSG-12 samples to validate the STRAT4 test and prognostic signature are then planned subsequently.
The ABCSG TR ProCan collaboration is an analysis of protein expression to develop a proteomic signature of distant recurrence in hormone receptor-positive (HR+) early breast cancer. The Children’s Medical Research Institute (CMRI) in Sydney Australia acts as a sponsor for this project, using samples and HE-stained slides from the ABCSG-6 trial cohort, and afterwards also the ABCSG-8 trial patients.
ABCSG TR Artera is a digital imaging project in cooperation with the US based company Artera to develop and evaluate a predictive algorithm via artificial intelligence for tailored treatment decisions in breast cancer patients. In a first step, digitized HE-slides of ABCSG-6 and ABCSG-8 cohort biosamples are planned to be used as training cohort, with further ABCSG trial populations planned to serve as validation cohorts for the signature.