Praegnant Breast Cancer: Early/Advanced/Metastatic
Recruiting · NCT02338167 · Observational (researchers observe without assigning treatment) · Lead sponsor: University Hospital Tuebingen
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Among patients with breast cancer the subgroup of patients with metastases are considered the group of patients with the worst prognosis. Not only regard-ing therapy decisions but also with regard to quality assured healthcare and health economics this entity of patients remains a challenge. Recently, novel advances in breast cancer therapy aim at the targeted therapy of tumor entities and identification of patients, for whom the greatest therapy benefit, and the least side effects are expected. However molecular assessment of the patient and the tumor in the metastatic situation is not performed on a routine basis and in many cases tumor character-istics from the primary tumor are considered reliable enough to make therapy decisions for the metastatic patients. Although molecular reassessment of tu-mor characteristics from tumor material of the metastasis is recommended in national guidelines, only a minority of patients is biopsied, because of the inva-siveness of the procedure, even though biopsy related complications are reported to be rare. With modern analytic methods from blood based biomaterial there seems to be an opportunity to correlate blood based tumor assessments with actual charac-teristics of the tumor. These include expression analysis, tumor mutation analy-sis, tumor gene copy number aberrations and others. One of the main aims of the PRAEGNANT study is therefore to establish an infrastructure for the compre-hensive analysis of tumor and metastatic molecular characteristics of the patient and the tumor. Furthermore, health care related outcomes as well as health economics provide novel approaches for integration of patients in study conduct and health care awareness and are study aims of the PRAEGNANT study.
Who can take part
Inclusion criteria
- for the early breast cancer setting:
- Adult breast cancer patients (age ≥18 years)
- Patients with breast cancer and no evidence of distant metastases with a diagnosis not longer than 91 days before study entry
- Patients, who are able and willing to sign the informed consent form
- Inclusion Criteria for the advanced/metastatic setting:
- Adult women aged ≥18 years
- Patients with the diagnosis of invasive breast cancer (in German: Mammakarzinom, as op-posed to "non-invasive"= ductales Carcinoma in situ; irrespective of status of BC, e.g. TNM, re-ceptor status etc.) and
- Patients, who are willing and able to sign the informed consent form
- Patients with metastatic or locally advanced, inoperable disease proven by clinical measures (i.e. standard imaging)
Exclusion criteria
- Patients who did not sign the informed consent form
- Patients, who are not eligible for observation due to non-availability and/or severe comor-bidities as evaluated by the treating physician
Where it is running
60 locations listed.
- medius KLINIKEN gGmbH, medius KLINIK Ostfildern-Ruit - Ostfildern, Germany
- Klinikum Sindelfingen-Böblingen gGmbH - Böblingen, Baden-Wurttemberg, Germany
- Klinik für Frauenheilkunde, Universitätsklinikum Freiburg - Freiburg im Breisgau, Baden-Wurttemberg, Germany
- NCT Heidelberg - Heidelberg, Baden-Wurttemberg, Germany
- ViDia Christliche Kliniken Karlsruhe - Karlsruhe, Baden-Wurttemberg, Germany
- Praxisklinik am Rosengarten - Mannheim, Baden-Wurttemberg, Germany
- medius Klinik Nürtingen - Nürtingen, Baden-Wurttemberg, Germany
- Universitätsfrauenklinik Tübingen - Tübingen, Baden-Wurttemberg, Germany
- Universitätsfrauenklinik Ulm - Ulm, Baden-Wurttemberg, Germany
- Gesundheitszentrum St. Marien GmbH - Amberg, Bavaria, Germany
- Anregiomed gKK Klinikum Ansbach Brustzentrum Westmittelfranken - Ansbach, Bavaria, Germany
- Hämatologische-onkologische Praxis - Augsburg, Bavaria, Germany
- Klinikum Augsburg - Augsburg, Bavaria, Germany
- Sozialstiftung Bamberg Klinikum am Bruderwald - Bamberg, Bavaria, Germany
- Klinikum Bayreuth - Bayreuth, Bavaria, Germany
- DONAUISAR Klinikum - Deggendorf, Bavaria, Germany
- Onkologisches Zentrum Donauwörth - Donauwörth, Bavaria, Germany
- Rottal-Inn-Kliniken GmbH - Eggenfelden, Bavaria, Germany
- Universitätsfrauenklinik Erlangen - Erlangen, Bavaria, Germany
- Klinikum Fürth - Fürth, Bavaria, Germany
- MVZ am Klinikum Aschaffenburg - Zweigpraxis für Hämatologie und Onkologie - Hösbach, Bavaria, Germany
- Onkologie Elisenhof, München - München, Bavaria, Germany
- Klinikum der Universität München Frauenklinik - München, Bavaria, Germany
- Frauenklinik und Poliklinik der Technischen Universität München - München, Bavaria, Germany
- Caritas-Krankenhaus St. Josef - Regensburg, Bavaria, Germany
- Universitätsklinikum Würzburg - Würzburg, Bavaria, Germany
- Praxis für Frauenheilkunde und Geburtshilfe - Fürstenwalde, Brandenburg, Germany
- Ruppiner Kliniken GmbH, Hochschulklinikum der Med. Hochschule Brandenburg - Neuruppin, Brandenburg, Germany
- Immanuel Klinik und Poliklinik Rüdersdorf GmbH - Rüdersdorf, Brandenburg, Germany
- Universitätsklinikum Hamburg-Eppendorf - Hamburg, Free and Hanseatic City of Hamburg, Germany
- Onkologie Lerchenfeld - Hamburg, Free and Hanseatic City of Hamburg, Germany
- Klinikum Darmstadt Frauenklinik - Darmstadt, Hesse, Germany
- Centrum für Hämatologie und Onkologie Bethanien - Frankfurt am Main, Hesse, Germany
- Klinikum Kassel GmbH - Kassel, Hesse, Germany
- Gemeinschaftspraxis für Hämatologie und Onkologie - Langen, Hesse, Germany
- Lahn-Dill-Kliniken GmbH Klinikum Wetzlar - Wetzlar, Hesse, Germany
- Niels-Stensen-Kliniken - Georgsmarienhütte, Lower Saxony, Germany
- Onkologische Schwerpunktpraxis Leer-Emden - Leer, Lower Saxony, Germany
- g.SUND Gynäkologie Kompetenzzentrum Stralsund - Stralsund, Mecklenburg-Vorpommern, Germany
- Uniklinik RWTH Aachen - Aachen, North Rhine-Westphalia, Germany
- Gynäkologie und Geburtshilfe im medizinischen Zentrum Bonn - Bonn, North Rhine-Westphalia, Germany
- Marienhospital - Bottrop, North Rhine-Westphalia, Germany
- Universitätsfrauenklinik Düsseldorf - Düsseldorf, North Rhine-Westphalia, Germany
- Kliniken Essen-Mitte - Essen, North Rhine-Westphalia, Germany
- Study site - Herne, North Rhine-Westphalia, Germany
- Institut für Versorgungsforschung in der Onkologie GbR - Koblenz, North Rhine-Westphalia, Germany
- St. Vincenz-Krankenhaus GmbH - Paderborn, North Rhine-Westphalia, Germany
- Praxis Onkologie und Hämatologie - Recklinghausen, North Rhine-Westphalia, Germany
- Gesellschaft für Medizinische Studien Würselen - Würselen, North Rhine-Westphalia, Germany
- Schwerpunktpraxis für Hämatologie und Onkologie - Kaiserslautern, Rhineland-Palatinate, Germany
- Institut für Versorgungsforschung - Mayen, Rhineland-Palatinate, Germany
- Klinikum Chemnitz gGmbH - Chemnitz, Saxony, Germany
- Universitätsklinik Dresden - Dresden, Saxony, Germany
- Universitäres Krebszentrum Leipzig - Leipzig, Saxony, Germany
- Kreiskrankenhaus Torgau - Torgau, Saxony, Germany
- Universitätsklinikum Halle (Saale) - Halle, Saxony-Anhalt, Germany
- Klinik für Gynäkologie und Geburtshilfe - Kiel, Schleswig-Holstein, Germany
- Universitätsklinikum Schleswig-Holstein - Lübeck, Schleswig-Holstein, Germany
- Charité - Berlin, State of Berlin, Germany
- MediOnko-Institut GbR - Berlin, State of Berlin, Germany
Showing 60 of 61 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →