We have assembled a multidisciplinary team including biomarker researchers, cancer biologist, pathologist, gynecologic oncologist, proteomic technologists, and experts in biostatistics, epidemiology, and bioinformatics to establish a Biomarker Developmental Laboratory for the NCI's Early Detection Research Network with the objective to develop an in vitro diagnostic multivariate index assay (IVDMIA) to detect ovarian cancer at low tumor volume. The intended use of such a test is to further enrich ovarian cancer prevalence in high-risk populations to allow for cost-effective additional workup tests. The rationale is based on 1) prognosis of ovarian cancer patients, in addition to stage/grade at diagnosis, is affected by the initial size of the metastatic disease and the size of residual disease after cytoreductive surgery; and 2) newly developed cancer-specific biomarkers detecting mutant DNAs in liquid-based cervical cytology specimens and circulating tumor DNA (ctDNA) in plasma have demonstrated a remarkable specificity. We hypothesize that combining such biomarkers with additional sensitive and disease burden-associated biomarkers in an IVDMIA will allow us to detect ovarian cancer at low volume which currently represents an unmet clinical need.
The proposed Biomarker Developmental Laboratory for the NCI's Early Detection Research Network consortium will participate in the Consortium's collaborative projects and other activities. The objective of the proposed research project is to develop an in vitro diagnostic multivariate index assay (IVDMIA) for the detection of ovarian cancer early or at a low volume. An IVDMIA is a panel of biomarkers and an algorithm that combines results from multiple biomarkers into a single-value index score to be used as a clinical assay.
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