Clinical trial · Observational
Prevalence of BRCA in Patients With Ovarian Cancer
Prevalence of BRCA in Patients With Primary or Platinum Sensitive Recurrent Ovarian Cancer.
NCT02222883CI-TRIAL-00052290completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of this prospective registration and translational research study is to evaluate the praevalence of BRCA regarding germline and somatic mutations.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| BRCA Status | — | UNRESOLVED | — |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Testing of BRCA status regarding germline and somatic mutation | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- patients with primary diagnosis
- description
- patients with primary diagnosis of ovarian cancer for testing of BRCA status regarding germline and somatic mutation
- interventionNames
- Genetic: Testing of BRCA status regarding germline and somatic mutation
- label
- patients with platinum-sensitive recurrence
- description
- patients with platinum-sensitive recurrence of ovarian cancer for testing of BRCA status regarding germline and somatic mutation
- interventionNames
- Genetic: Testing of BRCA status regarding germline and somatic mutation
Primary outcomes (1)
- measure
- Germline alterations in BRCA1/2 (yes/no) and other ovarian cancer predisposing genes (yes/no; if yes which)
- timeFrame
- once per sample
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (5)
- DERIVEDKayali 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. PMID 42284542
- DERIVEDWeber-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. PMID 34963005
- DERIVEDSchouten 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. PMID 34593530
- DERIVEDHauke 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. PMID 33273034
- DERIVEDHauke 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.