Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
530 participants
OBSERVATIONAL
2015-03-31
2021-04-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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patients with primary diagnosis
patients with primary diagnosis of ovarian cancer for testing of BRCA status regarding germline and somatic mutation
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
Testing of BRCA status regarding germline and somatic mutation
Interventions
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Testing of BRCA status regarding germline and somatic mutation
Eligibility Criteria
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Inclusion Criteria
* 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
* Platinum-resistant or refractory disease.
* Paraffin embedded tumor samples not available.
18 Years
FEMALE
No
Sponsors
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AGO Research GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Philipp Harter, PhD MD
Role: STUDY_CHAIR
Kliniken Essen-Mitte, Germany
Locations
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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 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
Countries
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References
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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.
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.
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.
Other Identifiers
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AGO-TR 1
Identifier Type: -
Identifier Source: org_study_id
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