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

August 13, 2015 updated by: Fundación de investigación HM

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

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

230

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain
        • Hospital Universitario Ramón y Cajal
      • Madrid, Spain
        • Hospital Universitario HM Sanchinarro - Clara Campal Comprehensive Cancer Center
      • Pamplona, Spain
        • Complejo Hospitalario de Navarra
    • Madrid
      • Leganes, Madrid, Spain
        • Hospital Universitario Severo Ochoa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with advanced epithelial ovarian cancer (stage 1c or higher) since 2008

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Non

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación de investigación HM

Collaborators

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

July 1, 2016

Study Registration Dates

First Submitted

August 6, 2015

First Submitted That Met QC Criteria

August 13, 2015

First Posted (Estimate)

August 17, 2015

Study Record Updates

Last Update Posted (Estimate)

August 17, 2015

Last Update Submitted That Met QC Criteria

August 13, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESR-14-10537

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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