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The aim of this prospective registration and translational research study is to evaluate the praevalence of BRCA regarding germline and somatic mutations.
Explorative analysis will be performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients with primary diagnosis | patients with primary diagnosis of ovarian cancer for 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Testing of BRCA status regarding germline and somatic mutation | Genetic |
|
| Measure | Description | Time Frame |
|---|---|---|
| Germline alterations in BRCA1/2 (yes/no) and other ovarian cancer predisposing genes (yes/no; if yes which) | once per sample |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Measure | Description | 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 |
Inclusion Criteria:
Exclusion Criteria:
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500 consecutive patients (up to 250 patients with primary diagnosis and up to 250 patients with platinum-sensitive recurrence of ovarian cancer.
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| Name | Affiliation | Role |
|---|---|---|
| Philipp Harter, PhD MD | Kliniken Essen-Mitte, Germany | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité - Universitätsmedizin Berlin | Berlin | Germany | ||||
| Universitätsklinik Carl Gustav Carus |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42284542 | Derived | Kayali M, Hahnen E, Burges A, Reuss A, Caro-Valenzuela J, de Gregorio N, Heitz F, Schmidt S, Marme 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. Constitutional BRCA1 Promoter Methylation in Patients With Ovarian Cancer: Results of the Observational AGO-TR1 Study. JCO Precis Oncol. 2026 Jun;10(6):e2501230. doi: 10.1200/PO-25-01230. Epub 2026 Jun 12. | |
| 34963005 |
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EDTA Blood sample Tumorblock
| BRCAness tumor phenotype in ovarian cancer (yes/no). |
| once per sample |
| Differences of tumor samples from primary and relapsed disease | once per sample for each stage of disease |
| Patient Survey for perspectives and satisfaction regarding testing and counseling | 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 | once |
| Dresden |
| Germany |
| Evangelisches Krankenhaus | Düsseldorf | Germany |
| Kliniken Essen-Mitte | Essen | Germany |
| Universitätsklinikum Essen | Essen | Germany |
| Universitätsklinikum Frankfurt | Frankfurt am Main | Germany |
| Universitätsklinikum Hamburg-Eppendorf | Hamburg | Germany |
| Medizinische Hochschule Hannover | Hanover | 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 | Germany |
| Derived |
| Weber-Lassalle K, Ernst C, Reuss A, Mollenhoff K, Baumann K, Jackisch C, Hauke J, Dietrich D, Borde J, Park-Simon TW, Hanker L, Prieske K, Schmidt S, Weber-Lassalle N, Pohl-Rescigno E, Kommoss S, Marme F, Heitz F, Stingl JC, Schmutzler RK, Harter P, Hahnen E. Clonal Hematopoiesis-Associated Gene Mutations in a Clinical Cohort of 448 Patients With Ovarian Cancer. J Natl Cancer Inst. 2022 Apr 11;114(4):565-570. doi: 10.1093/jnci/djab231. |
| 34593530 | Derived | Schouten PC, Richters L, Vis DJ, Kommoss S, van Dijk E, Ernst C, Kluin RJC, Marme F, Lips EH, Schmidt S, Scheerman E, Prieske K, van Deurzen CHM, Burges A, Ewing-Graham PC, Dietrich D, Jager A, de Gregorio N, Hauke J, du Bois A, Nederlof PM, Wessels LF, Hahnen E, Harter P, Linn SC, Schmutzler RK. Ovarian Cancer-Specific BRCA-like Copy-Number Aberration Classifiers Detect Mutations Associated with Homologous Recombination Deficiency in the AGO-TR1 Trial. Clin Cancer Res. 2021 Dec 1;27(23):6559-6569. doi: 10.1158/1078-0432.CCR-21-1673. Epub 2021 Sep 30. |
| 33273034 | Derived | Hauke J, Harter P, Ernst C, Burges A, Schmidt S, Reuss A, Borde J, De Gregorio N, Dietrich D, El-Balat A, Kayali M, Gevensleben H, Hilpert F, Altmuller J, Heimbach A, Meier W, Schoemig-Markiefka B, Thiele H, Kimmig R, Nurnberg P, Kast K, Richters L, Sehouli J, Schmutzler RK, Hahnen E. 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). J Med Genet. 2022 Mar;59(3):248-252. doi: 10.1136/jmedgenet-2020-107353. Epub 2020 Dec 3. |
| 30979843 | Derived | Hauke J, Hahnen E, Schneider S, Reuss A, Richters L, Kommoss S, Heimbach A, Marme F, Schmidt S, Prieske K, Gevensleben H, Burges A, Borde J, De Gregorio N, Nurnberg P, El-Balat A, Thiele H, Hilpert F, Altmuller J, Meier W, Dietrich D, Kimmig R, Schoemig-Markiefka B, Kast K, Braicu E, Baumann K, Jackisch C, Park-Simon TW, Ernst C, Hanker L, Pfisterer J, Schnelzer A, du Bois A, Schmutzler RK, Harter P. Deleterious somatic variants in 473 consecutive individuals with ovarian cancer: results of the observational AGO-TR1 study (NCT02222883). J Med Genet. 2019 Sep;56(9):574-580. doi: 10.1136/jmedgenet-2018-105930. Epub 2019 Apr 12. |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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