Clinical trial NCT02222883: Prevalence of BRCA in Patients With Ovarian Cancer
Official title: Prevalence of BRCA in Patients With Primary or Platinum Sensitive Recurrent Ovarian Cancer.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: BRCA Status
Ovarian Cancer
Lead sponsor: AGO Research GmbH
Sponsor class: INDUSTRY
First posted: 2014-08-21
Enrollment: 530
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 500 consecutive patients (up to 250 patients with primary diagnosis and up to 250 patients with platinum-sensitive recurrence of 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.

Eligibility criteria: 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.

Primary outcomes:
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:
measure: Results of Immunohistochemistry in tumor samples
timeFrame: once per sample
measure: Somatic alterations in BRCA1/2 (yes/no) and other ovarian cancer predisposing genes (yes/no; if yes which)
timeFrame: once per sample
measure: BRCAness tumor phenotype in ovarian cancer (yes/no).
timeFrame: once per sample
measure: Differences of tumor samples from primary and relapsed disease
timeFrame: once per sample for each stage of disease
measure: Patient Survey for perspectives and satisfaction regarding testing and counseling
timeFrame: once after BRCA result is available
measure: Determining the correlation of genetic alterations, cancer treatments, overall survival, progression-free survival and occurrence of new malignancies
timeFrame: once
Other outcomes:
measure: Validate the results from Pennington et al. (Pennington et al. Clin Cancer Res 2014)
timeFrame: once
measure: Evaluate predictive value of PARp-1 expression for HRD mutations
timeFrame: once for all samples
Locations:
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Dresden
country: Germany
facility: Universitätsklinik Carl Gustav Carus
city: Düsseldorf
country: Germany
facility: Evangelisches Krankenhaus
city: Essen
country: Germany
facility: Kliniken Essen-Mitte
city: Essen
country: Germany
facility: Universitätsklinikum Essen
city: Frankfurt/Main
country: Germany
facility: Universitätsklinikum Frankfurt
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Heidelberg
country: Germany
facility: NCT Heidelberg
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
city: Kiel
country: Germany
facility: Zentrum für Gynäkologische Onkologie
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
city: Marburg
country: Germany
facility: Universitätsklinikum Gießen und Marburg
city: München
country: Germany
facility: Klinikum rechts der Isar
city: München
country: Germany
facility: LMU München, Klinik Großhadern
city: Offenbach
country: Germany
facility: Sana Klinikum Offenbach
city: Tübingen
country: Germany
facility: Universitäts-Frauenklinik
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
city: Wiesbaden
country: Germany
facility: Dr. Horst Schmidt Kliniken
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg
Study officials:
affiliation: Kliniken Essen-Mitte, Germany
name: Philipp Harter, PhD MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.