Prevalence of BRCA in Patients With Ovarian Cancer

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02222883
• Other study ID #: AGO-TR 1
• Status: Completed
• Start date: March 2015
• Est. completion date: April 1, 2021

Study information

• Verified date: June 2021
• Source: AGO Research GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

Explorative analysis will be performed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 530
• Est. completion date: April 1, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• BRCA Status
• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Genetic:
• Testing of BRCA status regarding germline and somatic mutation

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AGO Research GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Validate the results from Pennington et al. (Pennington et al. Clin Cancer Res 2014)		once
Other	Evaluate predictive value of PARp-1 expression for HRD mutations		once for all samples
Primary	Germline alterations in BRCA1/2 (yes/no) and other ovarian cancer predisposing genes (yes/no; if yes which)		once per sample
Secondary	Results of Immunohistochemistry in tumor samples		once per sample
Secondary	Somatic alterations in BRCA1/2 (yes/no) and other ovarian cancer predisposing genes (yes/no; if yes which)		once per sample
Secondary	BRCAness tumor phenotype in ovarian cancer (yes/no).		once per sample
Secondary	Differences of tumor samples from primary and relapsed disease		once per sample for each stage of disease
Secondary	Patient Survey for perspectives and satisfaction regarding testing and counseling	3 questions	once after BRCA result is available
Secondary	Determining the correlation of genetic alterations, cancer treatments, overall survival, progression-free survival and occurrence of new malignancies		once