NCT02222883

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
530

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2015

Longer than P75 for all trials

Geographic Reach
1 country

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 21, 2014

Completed
6 months until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

June 16, 2021

Status Verified

June 1, 2021

Enrollment Period

6.1 years

First QC Date

August 19, 2014

Last Update Submit

June 11, 2021

Conditions

BRCA StatusOvarian Cancer

Outcome Measures

Primary Outcomes (1)

  • Germline alterations in BRCA1/2 (yes/no) and other ovarian cancer predisposing genes (yes/no; if yes which)

    once per sample

Secondary Outcomes (6)

  • 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

  • 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

    once after BRCA result is available

  • +1 more secondary outcomes

Other Outcomes (2)

  • 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

Study Arms (2)

patients with primary diagnosis

patients with primary diagnosis of ovarian cancer for testing of BRCA status regarding germline and somatic mutation

Genetic: 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

Genetic: Testing of BRCA status regarding germline and somatic mutation

Interventions

Testing of BRCA status regarding germline and somatic mutationGENETIC
patients with platinum-sensitive recurrencepatients with primary diagnosis

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • Non-epithelial ovarian malignancy.
  • Platinum-resistant or refractory disease.
  • Paraffin embedded tumor samples not available.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Charité - Universitätsmedizin Berlin

Berlin, Germany

Location

Universitätsklinik Carl Gustav Carus

Dresden, Germany

Location

Evangelisches Krankenhaus

Düsseldorf, Germany

Location

Kliniken Essen-Mitte

Essen, Germany

Location

Universitätsklinikum Essen

Essen, Germany

Location

Universitätsklinikum Frankfurt

Frankfurt am Main, Germany

Location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Germany

Location

Medizinische Hochschule Hannover

Hanover, Germany

Location

NCT Heidelberg

Heidelberg, Germany

Location

Universitätsklinikum Schleswig-Holstein

Kiel, Germany

Location

Zentrum für Gynäkologische Onkologie

Kiel, Germany

Location

Universitätsklinikum Schleswig-Holstein

Lübeck, Germany

Location

Universitätsklinikum Gießen und Marburg

Marburg, Germany

Location

Klinikum rechts der Isar

München, Germany

Location

LMU München, Klinik Großhadern

München, Germany

Location

Sana Klinikum Offenbach

Offenbach, Germany

Location

Universitäts-Frauenklinik

Tübingen, Germany

Location

Universitätsklinikum Ulm

Ulm, Germany

Location

Dr. Horst Schmidt Kliniken

Wiesbaden, Germany

Location

Universitätsklinikum Würzburg

Würzburg, Germany

Location

Related Publications (3)

  • 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.

    PMID: 34593530DERIVED

  • 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.

    PMID: 33273034DERIVED

  • 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.

    PMID: 30979843DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

EDTA Blood sample Tumorblock

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • Philipp Harter, PhD MD

    Kliniken Essen-Mitte, Germany

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2014

First Posted

August 21, 2014

Study Start

March 1, 2015

Primary Completion

April 1, 2021

Study Completion

April 1, 2021

Last Updated

June 16, 2021

Record last verified: 2021-06

Locations

DE(20)