The main objective of this study (LIBINI-1 first part) is characterizing liquid biopsy profiles of ovarian cancer patients with sustained niraparib benefit as maintenance in the first line through proteomic and secretome analysis. The first part of LIBINI-1 is addressed by four individual subsequent objectives (see ANNEX 2).
Therefore, the primary objective is the development of a panel for multiplex detection of proteins associated with sustained benefit from niraparib maintenance.
For the execution of the primary objective the following consecutive secondary objectives are planned:
1. Global characterization of proteins (proteome) in plasma samples from patients with and without benefit from niraparib maintenance. Identification of molecular pathways of proteins differentially expressed between both groups.
2. Analysis of secreted proteins (secretome) in plasma samples of patients with and without benefit from niraparib maintenance.
3 \& 4: Development of customized panels for multiplex detection of proteins associated with sustained benefit from niraparib maintenance.
After this discovery phase, the predictive panel should be validated in a confirmatory study with a larger cohort of advanced ovarian cancer patient samples.
The second part of LINIBI-1 is to correlate the baseline levels of ctDNA and the changes in ctDNA at 4 and 12 weeks (3 months) with benefit to niraparib. This second part of LIBINI-I will be analyzed in a subsequent study.
