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BRCA StatusNCT02222883

Prevalence of BRCA in Patients With Ovarian Cancer

An observational study of BRCA Status and Ovarian Cancer, run by AGO Research GmbH at 20 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
BRCA Status, Ovarian Cancer
What is being tested?
Testing of BRCA status regarding germline and somatic mutation
How many people
530 participants
Where
20 sitesGermany
Study dates
Mar 2015to 1 Apr 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: 500 consecutive patients (up to 250 patients with primary diagnosis and up to 250 patients with platinum-sensitive recurrence of ovarian cancer.

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

Germany20 sites

  • Charité - Universitätsmedizin Berlin

    Berlin

  • Universitätsklinik Carl Gustav Carus

    Dresden

  • Evangelisches Krankenhaus

    Düsseldorf

  • Kliniken Essen-Mitte

    Essen

  • Universitätsklinikum Essen

    Essen

  • Universitätsklinikum Frankfurt

    Frankfurt am Main

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg

  • Medizinische Hochschule Hannover

    Hanover

  • NCT Heidelberg

    Heidelberg

  • Universitätsklinikum Schleswig-Holstein

    Kiel

  • Zentrum für Gynäkologische Onkologie

    Kiel

  • Universitätsklinikum Schleswig-Holstein

    Lübeck

  • Universitätsklinikum Gießen und Marburg

    Marburg

  • Klinikum rechts der Isar

    München

  • LMU München, Klinik Großhadern

    München

  • Sana Klinikum Offenbach

    Offenbach

  • Universitäts-Frauenklinik

    Tübingen

  • Universitätsklinikum Ulm

    Ulm

  • Dr. Horst Schmidt Kliniken

    Wiesbaden

  • Universitätsklinikum Würzburg

    Würzburg

Other trials in Germany

About this study

Official title: Prevalence of BRCA in Patients With Primary or Platinum Sensitive Recurrent Ovarian Cancer.

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

Read the detailed description

Explorative analysis will be performed.

Being tested
Testing of BRCA status regarding germline and somatic mutation
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Testing of BRCA status regarding germline and somatic mutationGenetic

Study groups in NCT02222883
Study groupRoleWhat they receive
patients with primary diagnosispatients with primary diagnosis of ovarian cancer for testing of BRCA status regarding germline and somatic mutation
Receives: Genetic: Testing of BRCA status regarding germline and somatic mutation
patients with platinum-sensitive recurrencepatients with platinum-sensitive recurrence of ovarian cancer for testing of BRCA status regarding germline and somatic mutation
Receives: Genetic: Testing of BRCA status regarding germline and somatic mutation

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: once per sample

Secondary outcomes (6)

  1. Results of Immunohistochemistry in tumor samples

    Measured: once per sample

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

    Measured: once per sample

  3. BRCAness tumor phenotype in ovarian cancer (yes/no).

    Measured: once per sample

  4. Differences of tumor samples from primary and relapsed disease

    Measured: once per sample for each stage of disease

  5. Patient Survey for perspectives and satisfaction regarding testing and counseling

    3 questions

    Measured: once after BRCA result is available

  6. Determining the correlation of genetic alterations, cancer treatments, overall survival, progression-free survival and occurrence of new malignancies

    Measured: once

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2014 (estimated)
  2. Study startMar 2015
  3. Primary completion1 Apr 2021
  4. Study completion1 Apr 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
530 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02222883
Sponsor's protocol ID
AGO-TR 1
Status last verified
Jun 2021
First submitted
19 Aug 2014
Last updated
16 Jun 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 42284542

  • 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.

    PubMed 34963005

  • 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.

    PubMed 34593530

  • 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.

    PubMed 33273034

  • 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.

    PubMed 30979843

Questions about this trial

What is this clinical trial studying?

An observational study of BRCA Status and Ovarian Cancer, run by AGO Research GmbH at 20 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Germline alterations in BRCA1/2 (yes/no) and other ovarian cancer predisposing genes (yes/no; if yes which) (time frame: once per sample). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02222883, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2021.

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