The Pathology TF is the latest addition to the CCE family with a remit to establish standardized diagnostic pathology platforms within CCE, and to provide specialist pathology expertise to support new clinical trials and novel arms of the BoB trial. The main goals of this TF are:
- The development of common protocols for CCE trial sample collection, quality assurance, data collection and reporting.
- To implement a virtual CCE sample biorepository including digital images which will be integrated with other existing patient and molecular data platforms.
- To conduct interlaboratory ring studies for routine and new biomarker assessment within CCE laboratories to ensure reproducibility and uniformity of practice.
- The introduction of new initiatives in the field of diagnostic, molecular and digital pathology contributing to the overall CCE strategy.
For the period 2020-2022, the main focus of the Pathology TF is to resolve key challenges within clinical trials, translational research and the virtual data centre. Firstly, the BoB trial revealed challenges from a clinical trial management perspective. Connectivity was limited between the clinical database and the genomic data repository, with a lack of centralized information on samples collected within the study. A priority for the Pathology Task Force is to create a tool for visualization of patient samples in terms of location, availability and quality, and to embed that information into the clinical trial management tool.
Second, BoB relies on molecular profiling of tumour samples collected at the trial centres. Accurate molecular profiling requires adequate tumour content with minimal contamination by normal cells to avoid false negative results. Pathologists within each CCE centre assess tumour content within the sample prior to molecular analysis, however this is a subjective process affected by reproducibility issues which may impact the quality of downstream results. To address this, the TF is conducting a ring study looking at reproducibility of cellularity assessment in the BoB trial. This will provide baseline information regarding consistency within and between centres from which more standardized methods can be developed, and for the establishment of minimum criteria for sample adequacy to improve the efficiency and success rate of molecular analysis.