Prevalence of BRCA in Patients With Ovarian Cancer

Conditions

BRCA Status, Ovarian Cancer

Brief summary

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

Detailed description

Explorative analysis will be performed.

Kayali M, Hahnen E, Burges A, Reuss A, Caro-Valenzuela J, de Gregorio N, Heitz F, Schmidt S, Marmé F, Hilpert F, Wimberger P, Kommoss S, Prieske K, Engel C, Buderath P, Dietrich D, Schmutzler R, Sehouli J, Rhiem K, Harter P, Hauke J.

2026-06-12

10.1200/po-25-01230

Susceptibility gene mutations in germline and tumors of patients with HER2-negative advanced breast cancer.

Fasching PA, Hu C, Hart SN, Ruebner M, Polley EC, Gnanaolivu RD, Hartkopf AD, Huebner H, Janni W, Hadji P, Tesch H, Uhrig S, Ettl J, Lux MP, Lüftner D, Wallwiener M, Wurmthaler LA, Goossens C, Müller V, Beckmann MW, Hein A, Anetsberger D, Belleville E, Wimberger P, Untch M, Ekici AB, Kolberg HC, Hartmann A, Taran FA, Fehm TN, Wallwiener D, Brucker SY, Schneeweiss A, Häberle L, Couch FJ.

2024-07-133 citations

10.1038/s41523-024-00667-x

Ovarian Cancer–Specific BRCA -like Copy-Number Aberration Classifiers Detect Mutations Associated with Homologous Recombination Deficiency in the AGO-TR1 Trial

Philip C. Schouten, Lisa Richters, Daniel J. Vis, Stefan Kommoss, Ewald van Dijk et al. (26 authors)

Clinical Cancer Research2021-09-3021 citations

10.1158/1078-0432.ccr-21-1673

Sensitivity and specificity of loss of heterozygosity analysis for the classification of rare germline variants in BRCA1/2: results of the observational AGO-TR1 study (NCT02222883)

Jan Hauke, Philipp Harter, Corinna Ernst, Alexander Burges, Sandra Schmidt et al. (25 authors)

Journal of Medical Genetics2020-12-034 citations

10.1136/jmedgenet-2020-107353

Deleterious somatic variants in 473 consecutive individuals with ovarian cancer: results of the observational AGO-TR1 study (NCT02222883)

Jan Hauke, Eric Hahnen, Stephanie Schneider, Alexander Reuß, Lisa Richters et al. (35 authors)

Journal of Medical Genetics2019-04-1241 citations

10.1136/jmedgenet-2018-105930

BRCA-like classification in ovarian cancer: Results from the AGO-TR1-trial.

Lisa Richters, Philip C. Schouten, Stefan Kommoss, Jan Hauke, Alexander Burges et al. (20 authors)

Journal of Clinical Oncology2017-05-203 citations

10.1200/jco.2017.35.15_suppl.5546

Prevalence of somatic mutations in risk genes including BRCA1/2 in consecutive ovarian cancer patients (AGO-TR-1 study).

Eric Hahnen, Klaus Baumann, André Heimbach, Alexander Reuß, Christian Jackisch et al. (20 authors)

Journal of Clinical Oncology2016-05-206 citations

10.1200/jco.2016.34.15_suppl.5544

Incidence of germline mutations in risk genes including BRCA1/2 in consecutive ovarian cancer (OC) patients (AGO TR-1).

Philipp Harter, Jan Hauke, Florian Heitz, Alexander Reuß, Stefan Kommoss et al. (20 authors)

Journal of Clinical Oncology2016-05-203 citations

10.1200/jco.2016.34.15_suppl.5538

Interventions

GENETICTesting of BRCA status regarding germline and somatic mutation

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

No

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.

Design outcomes

Primary

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

Secondary

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

Other

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

Countries

Germany

Outcome results

None listed