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

NCT ID: NCT02524808

Last Updated: 2015-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

230 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-08-31

Study Completion Date

2016-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Ovarian Neoplasms

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Non
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role collaborator

Fundación de investigación HM

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital Universitario Severo Ochoa

Leganés, Madrid, Spain

Site Status

Hospital Universitario HM Sanchinarro - Clara Campal Comprehensive Cancer Center

Madrid, , Spain

Site Status

Hospital Universitario Ramón y Cajal

Madrid, , Spain

Site Status

Complejo Hospitalario de Navarra

Pamplona, , Spain

Site Status

Countries

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Spain

Other Identifiers

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ESR-14-10537

Identifier Type: -

Identifier Source: org_study_id

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