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

Ovarian Neoplasms Clinical Trial

— FindBRCANess  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02524808
• Other study ID #: ESR-14-10537
• Status: Not yet recruiting
• Phase: N/A
• First received: August 6, 2015
• Last updated: August 13, 2015
• Start date: August 2015
• Est. completion date: July 2016

Study information

• Verified date: August 2015
• Source: Fundación de investigación HM
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 230
• Est. completion date: July 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Non

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Neoplasms, Glandular and Epithelial
• Ovarian Neoplasms

Locations

Country	Name	City	State
Spain	Hospital Universitario Severo Ochoa	Leganes	Madrid
Spain	Hospital Universitario HM Sanchinarro - Clara Campal Comprehensive Cancer Center	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid
Spain	Complejo Hospitalario de Navarra	Pamplona

Sponsors (2)

Lead Sponsor	Collaborator
Fundación de investigación HM	AstraZeneca

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year	No