Prospective Identification and Validation of BRCANess Profile in Ovarian Epithelial Cancer

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02524808

Acronym

FindBRCANess

Enrollment

230

Registered

2015-08-17

Start date

2015-08-31

Completion date

2016-07-31

Last updated

2015-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Neoplasms

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Non

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Spain

Outcome results