Multicentric Project for the Prospective Identification and Validation of Molecular Alterations That Define the "BRCANess" Profile in Ovarian Epithelial Cancer and Its Application as a Response Predictor to Platinum and Antitarget Therapies in the Clinical Practice. The Finding BRCANess Project
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Ovarian Neoplasms
- Sponsor
- Fundación de investigación HM
- Enrollment
- 230
- Locations
- 4
- Primary Endpoint
- Number of participants with a genetic profile defined by sequencing that could predict Progression Free Survival (PFS)
- Last Updated
- 10 years ago
Overview
Brief Summary
This is an observational prospective study. Patients diagnosed with advanced epithelial ovarian cancer (stage IC or higher) since 2008 will be asked to participate in this study by signing an informed consent. Tumour samples will be reviewed to confirm the diagnosis and to select the best regions for tissue sampling to perform the following molecular studies: array-based Comparative Genomic Hybridization and Next Generation Sequencing. Detected mutations will be analysed by Sanger sequencing. FISH probes will be designed and tested on the samples.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients diagnosed with advanced epithelial ovarian cancer (stage IC or higher).
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Number of participants with a genetic profile defined by sequencing that could predict Progression Free Survival (PFS)
Time Frame: 1 year
Clinical data from the enrolled patients will be recorded and related to the results obtained from sequencing the DNA isolated from tumor samples. Whole exome sequencing (WES) will be used for sequencing DNA isolated from paraffin embedded samples and Whole genome association study (GWAS) for the DNA from frozen samples. The bioinformatics analysis of the sequencing results will allow us to identify altered regions and affected genes and the minimal common regions of imbalance. All detected mutations will be confirmed by Sanger sequencing to ensure the reliability of the findings.