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

NCT02524808UNKNOWNOBSERVATIONAL

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.

Key Facts

Lead Sponsor

Fundación de investigación HM

Enrollment

230

Start Date

2015-08-01

Completion Date

2015-12-01

Study Type

OBSERVATIONAL

Official Title

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

Conditions

Ovarian Neoplasms

Eligibility

Sex

FEMALE

Inclusion Criteria:

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

Exclusion Criteria:

* Non

Outcome Measures

Primary Outcomes

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

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.

Time frame: 1 year

Locations

Hospital Universitario Severo Ochoa, Leganés, Spain

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

Hospital Universitario Ramón y Cajal, Madrid, Spain

Complejo Hospitalario de Navarra, Pamplona, Spain

Linked Diseases

Ovarian Neoplasms

Ovarian Neoplasms — a type of gynecological cancer.

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