Prospective Identification and Validation of "BRCANess" Profile in Ovarian Epithelial Cancer

• Conditions: Ovarian Neoplasms

• Registration Number: NCT02524808
• Lead Sponsor: Fundación de investigación HM

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-08
• Study Start: 2015-08
• Study First Submitted: 2015-08-06
• Study First Submitted QC: 2015-08-13
• Last Update Submitted: 2015-08-13
• Study First Posted: 2015-08-17
• Last Update Posted: 2015-08-17
• Primary Completion: 2015-12
• Study Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 230

Inclusion Criteria

• Patients diagnosed with advanced epithelial ovarian cancer (stage IC or higher).

Exclusion Criteria

• Non

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants with a genetic profile defined by sequencing that could predict Progression Free Survival (PFS)	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.

Trial Locations

Locations (4)

Hospital Universitario Severo Ochoa; 🇪🇸 Leganes, Madrid, Spain

Complejo Hospitalario de Navarra; 🇪🇸 Pamplona, Spain

Hospital Universitario HM Sanchinarro - Clara Campal Comprehensive Cancer Center; 🇪🇸 Madrid, Spain

Hospital Universitario Ramón y Cajal; 🇪🇸 Madrid, Spain