Prevalence of BRCA in Patients With Ovarian Cancer

June 11, 2021 updated by: AGO Research GmbH

Prevalence of BRCA in Patients With Primary or Platinum Sensitive Recurrent Ovarian Cancer.

The aim of this prospective registration and translational research study is to evaluate the praevalence of BRCA regarding germline and somatic mutations.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Explorative analysis will be performed.

Study Type

Observational

Enrollment (Actual)

530

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

  • Germany
      • Berlin, Germany
        • Charité - Universitätsmedizin Berlin
      • Dresden, Germany
        • Universitätsklinik Carl Gustav Carus
      • Düsseldorf, Germany
        • Evangelisches Krankenhaus
      • Essen, Germany
        • Universitätsklinikum Essen
      • Essen, Germany
        • Kliniken Essen-Mitte
      • Frankfurt/Main, Germany
        • Universitatsklinikum Frankfurt
      • Hamburg, Germany
        • Universitatsklinikum Hamburg-Eppendorf
      • Hannover, Germany
        • Medizinische Hochschule Hannover
      • Heidelberg, Germany
        • NCT Heidelberg
      • Kiel, Germany
        • Universitätsklinikum Schleswig-Holstein
      • Kiel, Germany
        • Zentrum für Gynäkologische Onkologie
      • Lübeck, Germany
        • Universitätsklinikum Schleswig-Holstein
      • Marburg, Germany
        • Universitätsklinikum Gießen und Marburg
      • München, Germany
        • Klinikum Rechts der Isar
      • München, Germany
        • LMU München, Klinik Großhadern
      • Offenbach, Germany
        • Sana Klinikum Offenbach
      • Tübingen, Germany
        • Universitäts-Frauenklinik
      • Ulm, Germany
        • Universitätsklinikum Ulm
      • Wiesbaden, Germany
        • Dr. Horst Schmidt Kliniken
      • Würzburg, Germany
        • Universitätsklinikum Würzburg

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

500 consecutive patients (up to 250 patients with primary diagnosis and up to 250 patients with platinum-sensitive recurrence of ovarian cancer.

Description

Inclusion Criteria:

  • Female ovarian cancer patients aged >= 18 years.
  • Women with first diagnosis of epithelial ovarian cancer OR women diagnosed with platinum-sensitive recurrent ovarian cancer.
  • Multiple platinum based prior therapies are allowed.

Exclusion Criteria:

  • Non-epithelial ovarian malignancy.
  • Platinum-resistant or refractory disease.
  • Paraffin embedded tumor samples not available.

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: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients with primary diagnosis
patients with primary diagnosis of ovarian cancer for testing of BRCA status regarding germline and somatic mutation
Genetic: Testing of BRCA status regarding germline and somatic mutation
patients with platinum-sensitive recurrence
patients with platinum-sensitive recurrence of ovarian cancer for testing of BRCA status regarding germline and somatic mutation
Genetic: Testing of BRCA status regarding germline and somatic mutation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Germline alterations in BRCA1/2 (yes/no) and other ovarian cancer predisposing genes (yes/no; if yes which)
Time Frame: once per sample
once per sample

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Results of Immunohistochemistry in tumor samples
Time Frame: once per sample
once per sample
Somatic alterations in BRCA1/2 (yes/no) and other ovarian cancer predisposing genes (yes/no; if yes which)
Time Frame: once per sample
once per sample
BRCAness tumor phenotype in ovarian cancer (yes/no).
Time Frame: once per sample
once per sample
Differences of tumor samples from primary and relapsed disease
Time Frame: once per sample for each stage of disease
once per sample for each stage of disease
Patient Survey for perspectives and satisfaction regarding testing and counseling
Time Frame: once after BRCA result is available
3 questions
once after BRCA result is available
Determining the correlation of genetic alterations, cancer treatments, overall survival, progression-free survival and occurrence of new malignancies
Time Frame: once
once

Other Outcome Measures

Outcome Measure
Time Frame
Validate the results from Pennington et al. (Pennington et al. Clin Cancer Res 2014)
Time Frame: once
once
Evaluate predictive value of PARp-1 expression for HRD mutations
Time Frame: once for all samples
once for all samples

Collaborators and Investigators

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

Sponsor

AGO Research GmbH

Investigators

  • Study Chair: Philipp Harter, PhD MD, Kliniken Essen-Mitte, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

March 1, 2015

Primary Completion (Actual)

April 1, 2021

Study Completion (Actual)

April 1, 2021

Study Registration Dates

First Submitted

August 19, 2014

First Submitted That Met QC Criteria

August 19, 2014

First Posted (Estimate)

August 21, 2014

Study Record Updates

Last Update Posted (Actual)

June 16, 2021

Last Update Submitted That Met QC Criteria

June 11, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AGO-TR 1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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