Prospective Identification and Validation of "BRCANess" Profile in Ovarian Epithelial Cancer
FindBRCANess
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
1 other identifier
observational
230
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2015
Shorter than P25 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 6, 2015
CompletedFirst Posted
Study publicly available on registry
August 17, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedAugust 17, 2015
August 1, 2015
4 months
August 6, 2015
August 13, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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
Eligibility Criteria
Patients diagnosed with advanced epithelial ovarian cancer (stage 1c or higher) since 2008
You may qualify if:
- Patients diagnosed with advanced epithelial ovarian cancer (stage IC or higher).
You may not qualify if:
- Non
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fundación de investigación HMlead
- AstraZenecacollaborator
Study Sites (4)
Hospital Universitario Severo Ochoa
Leganés, 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, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 6 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 6, 2015
First Posted
August 17, 2015
Study Start
August 1, 2015
Primary Completion
December 1, 2015
Study Completion
July 1, 2016
Last Updated
August 17, 2015
Record last verified: 2015-08