Abstract
Ovarian cancer is the most lethal gynecological cancer, and despite years of research, with the exception of a BRCA mutation driving the use of PARP inhibitors, no new prognostic/predictive biomarkers are clinically available. Improvement in biomarker selection and validation may derive from the systematic inclusion of translational analyses into the design of clinical trials. In the era of personalized medicine, the prospective centralized collection of high-quality biological material, expert pathological revision, and association to well-controlled clinical data are important or even essential added values to clinical trials. Here, we present the academic experience of the MITO (Multicenter Italian Trial in Ovarian Cancer) group, including gynecologists, pathologists, oncologists, biostatisticians, and translational researchers, whose effort is dedicated to the care and basic/translational research of gynecologic cancer. In our ten years of experience, we have been able to collect and process, for translational analyses, formalin-fixed, paraffin-embedded blocks from more than one thousand ovarian cancer patients. Standard operating procedures for collection, shipping, and processing were developed and made available to MITO researchers through the coordinating center’s web-based platform. Clinical data were collected through dedicated electronic case report forms hosted in a web-based electronic platform and stored in a central database at the trial’s coordinating center, which performed all the analyses related to the proposed translational researches. During this time, we improved our strategies of block management from retrospective to prospective collection, up to the design of a prospective collection with a quality check for sample eligibility before patients’ accrual. The final aim of our work is to share our experience by suggesting a guideline for the process of centralized collection, revision processing, and storing of formalin-fixed, paraffin-embedded blocks for translational purposes.
Highlights
The molecular characterization of epithelial ovarian cancer (EOC) in order to select or drive new drug development is perceived as a major goal by all the stakeholders in the field [1]
30 patients were excluded because their tumors were collected during interval debulking surgery after neo-adjuvant chemotherapy (NACT), or because the date of collection was unknown, and a further 25 were excluded because tumor blocks did not fulfill the criteria for RNA extraction
Drop-outs subsequent to pathological revision were due to withdrawn consent (1 patient); exclusion because tumors were collected after NACT, or because the date of collection was unknown (12 patients); and an insufficient amount of tumor tissue for IHC/RNA
Summary
The molecular characterization of epithelial ovarian cancer (EOC) in order to select or drive new drug development is perceived as a major goal by all the stakeholders in the field [1]. Among the potential flaws hindering the development of translational research in this field there are samples sizes, missing or imprecise clinical information, and a lack of rigorous statistical analysis. The collection of samples from clinical trials is a precious source for translational studies; examples of such bio-banking include the International Breast Cancer Study Group (IBCSG). Very few of these initiatives are conducted by academic institutions or group in a multicenter setting, mainly due to the scarcity of finances and complexity of the procedures. The accomplishment of this goal is one of the aims of the MITO
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