Evidence map›Paper›PMID 36409394›Full record

ArticleBreast cancer research and treatment2023

Return of individual genomic research results within the PRAEGNANT multicenter registry study.

Hanna Huebner, Matthias Ruebner, Christian Kurbacher, Peyman Hadji, Andreas D Hartkopf, Michael P Lux, Jens Huober, Sabrina Uhrig, Florin-Andrei Taran, Friedrich Overkamp and 18 more

Abstract readMulticenter Study
In one paragraph

Article in Breast cancer research and treatment, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Genomic Data Governance Challenges Between Research and Clinical Care: A Scoping Review.Health expectations : an international journal of public participation in health care and health policy · 2026
    Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

28 authors.

Hanna HuebnerDepartment of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-EMN, University Hospital Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Erlangen, Germany.
Matthias RuebnerDepartment of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-EMN, University Hospital Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Erlangen, Germany.
Christian KurbacherDepartment of Gynecology and Obstetrics, Medizinisches Zentrum Bonn Friedensplatz, Bonn, Germany.
Peyman HadjiFrankfurt Center for Bone Health, 60313, Frankfurt, Germany.
Andreas D HartkopfDepartment of Obstetrics and Gynecology, University of Tübingen, Tübingen, Germany.
Michael P LuxKlinik Für Gynäkologie und Geburtshilfe Frauenklinik St. Louise, St. Josefs-Krankenhaus, Salzkotten, Kooperatives Brustzentrum Paderborn, Paderborn, Germany.
Jens HuoberDepartment of Gynecology and Obstetrics, Ulm University Hospital, Ulm, Germany.
Sabrina UhrigDepartment of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-EMN, University Hospital Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Erlangen, Germany.
Florin-Andrei TaranDepartment of Obstetrics and Gynecology, University of Tübingen, Tübingen, Germany.
Friedrich OverkampOncoConsult Overkamp GmbH, Berlin, Germany.
Hans TeschOncology Practice at Bethanien Hospital Frankfurt, Frankfurt, Germany.
Lothar HäberleDepartment of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-EMN, University Hospital Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Erlangen, Germany.
Diana LüftnerImmanuel Hospital Märkische Schweiz, Buckow, Germany.
Markus WallwienerDepartment of Obstetrics and Gynecology, University of Heidelberg, Heidelberg, Germany.
Volkmar MüllerDepartment of Gynecology, Hamburg-Eppendorf University Medical Center, Hamburg, Germany.
Matthias W BeckmannDepartment of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-EMN, University Hospital Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Erlangen, Germany.
Alexander HeinDepartment of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-EMN, University Hospital Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Erlangen, Germany.
Erik BellevilleClinSol, GmbH & Co KG, Würzburg, Germany.
Michael UntchDepartment of Gynecology and Obstetrics, Helios Clinics Berlin Buch, Berlin, Germany.
Wolfgang JanniDepartment of Gynecology and Obstetrics, Ulm University Hospital, Ulm, Germany.
Tanja N FehmDepartment of Gynecology and Obstetrics, University Hospital of Düsseldorf, Düsseldorf, Germany.
Hans-Christian KolbergMarienhospital Bottrop, Bottrop, Germany.
Diethelm WallwienerDepartment of Obstetrics and Gynecology, University of Tübingen, Tübingen, Germany.
Sara Y BruckerDepartment of Obstetrics and Gynecology, University of Tübingen, Tübingen, Germany.
Andreas SchneeweissNational Center for Tumor Diseases, University Hospital and German Cancer Research Center, Heidelberg, Germany.
Johannes EttlDepartment of Obstetrics and Gynecology, Klinikum rechts der Isar, Technical University of Munich, Munich, Germany.
Peter A FaschingDepartment of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-EMN, University Hospital Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Erlangen, Germany. peter.fasching@uk-erlangen.de.ORCID http://orcid.org/0000-0003-4885-8471
Laura L MichelNational Center for Tumor Diseases, University Hospital and German Cancer Research Center, Heidelberg, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe PRAEGNANT study is a registry study for metastatic breast cancer patients, focusing on biomarker detection. Recently, within this study, genetic alterations in 37 breast cancer predisposition genes were analyzed and genetic findings were detected for 396 participants. The aim of this project was to return genetic results to the physicians and to analyze actions taken (e.g., disclosure of results to patients, validation of results, clinical impact, and impact on the patient's quality of life) using a questionnaire.

methods235 questionnaires were sent out to the study centers, with each questionnaire representing one patient with a genetic finding. The questionnaire consisted of twelve questions in the German language, referring to the disclosure of results, validation of test results, and their impact on treatment decisions and on the patient's quality of life.

results135 (57.5%) questionnaires were completed. Of these, 46 (34.1%) stated that results were returned to the patients. In 80.0% (N = 36) of cases where results were returned, the patient had not been aware of the finding previously. For 27 patients (64.3%), genetic findings had not been validated beforehand. All validation procedures (N = 15) were covered by the patients' health insurance. For 11 (25.0%) patients, physicians reported that the research results influenced current or future decision-making on treatment, and for 37.8% (N = 17) the results influenced whether family members will be genetically tested.

conclusionThis study provides novel insights into the return of research results and into clinical and personal benefits of disclosure of genetic findings within a German registry.

Indexed as

Breast NeoplasmsDisclosureFemaleGenomicsHumansQuality of LifeRegistriesSurveys and QuestionnairesBreast cancerGenetic testingIncidental findingsResearch resultsReturn of results

Identifiers

PMID36409394
PMCPMC9822879

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.