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Feasibility of a large multi-center translational research project for newly diagnosed breast and ovarian cancer patients with affiliated biobank: the BRandO biology and outcome (BiO)-project

  • Amelie De GregorioEmail author
  • Gabriele Nagel
  • Peter Möller
  • Andreas Rempen
  • Erik Schlicht
  • Steffen Fritz
  • Felix Flock
  • Thorsten Kühn
  • Falk Thiel
  • Ricardo Felberbaum
  • Florian Ebner
  • Nikolaus De Gregorio
  • Thomas Wolfram Paul Friedl
  • Lisa Wiesmüller
  • Peter Kuhn
  • Margit Schmitt
  • Wolfgang Janni
  • Dietrich Rothenbacher
  • Jens Huober
Gynecologic Oncology

Abstract

Introduction

Large translational research projects may contribute to further progress in cancer treatment by exploring molecular biology, immunologic approaches and identification of new prognostic and predictive factors. Therefore, the BRandOBio-project combines a clinical registry for collection of patient and tumor characteristics with a biobank comprising tumor and liquid biopsies. In addition, sociodemographic, environmental and lifestyle factors of included patients with primary newly diagnosed breast or ovarian cancer, other rare malignant ovarian tumors or gestational trophoblastic disease are prospectively collected.

Methods

The target population includes the German “Alb-Allgäu-Bodensee Region” which constitutes the outreach area of the University Hospital Ulm with affiliated academic centers and private practices. Clinical data combined with primary tumor tissue samples and longitudinal repeatedly collected blood samples [before, 6 (in high-risk situations), 12, 36 and 60 months after treatment and at relapse] will be acquired from more than 4000 patients within the next years. Standardized questionnaires are given to patients of the University Hospital Ulm and eight selected external sites for assessing life style and cancer risk factors. Concomitantly, storage of paraffin-embedded tumor samples as well as liquid biopsy samples will allow translational research projects, for example in terms of investigating circulating DNA and germ line DNA from cell pellets.

Results

Starting in January 2016 at the University Hospital Ulm, 19 additional external sites started recruiting patients in March 2017. As of September 15th 2019, 2151 patients with newly diagnosed cancers could be recruited (2044 breast cancer; 107 ovarian cancer). Nearly all patients provided biological samples (tumor and liquid biopsy) and about 80% returned the standardized questionnaire. After 1 year follow-up, blood samples were available from more than 80% of the participating patients.

Conclusions

The BRandO BIO study is a large prospective cohort study with integrated comprehensive biobank and evaluation of sociodemographic and life style factors of gynecological cancer patients in a well-defined geographical area in the South West of Germany. Continuous high patient recruitment and stable rates over 80% for returned questionnaires as well as for repeated blood sampling show high acceptance of the BRandO study program and confirms feasibility of the project.

Keywords

Breast cancer Ovarian cancer Translational research Circulating tumor DNA Epidemiology Biobank Clinical registry 

Notes

Acknowledgements

We thank all the patients for participating in this study and donating their blood samples for research purposes.

Author contributions

AdG: protocol/project development, data collection and management, manuscript writing; GN: project development, data collection, manuscript writing; PM: project development, data management; AR, ES, SF, FF, TK, FT, RF, FE, NdG, WJ: data collection; TWPF: project development, data management; LW: project development, sample and data management, manuscript editing; PK: data management, manuscript design; MS: data management, manuscript writing; DR: data management, manuscript editing; JH: protocol/project development, data collection and management, manuscript writing.

Funding

External funding was provided by Celgene.

Compliance with ethical standards

Conflict of interest

JH: Celgene. The other authors declare that they have no conflict of interest.

Ethical approval

Study protocol and patient informed consent have been approved by the local ethic committee and are in accordance with the Declaration of Helsinki.

Informed consent

Informed consent was obtained from all individual participants included in the study.

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Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2019

Authors and Affiliations

  • Amelie De Gregorio
    • 1
    Email author
  • Gabriele Nagel
    • 2
  • Peter Möller
    • 3
  • Andreas Rempen
    • 4
  • Erik Schlicht
    • 5
  • Steffen Fritz
    • 6
  • Felix Flock
    • 7
  • Thorsten Kühn
    • 8
  • Falk Thiel
    • 9
  • Ricardo Felberbaum
    • 10
  • Florian Ebner
    • 11
  • Nikolaus De Gregorio
    • 1
  • Thomas Wolfram Paul Friedl
    • 1
  • Lisa Wiesmüller
    • 1
  • Peter Kuhn
    • 12
  • Margit Schmitt
    • 1
  • Wolfgang Janni
    • 1
  • Dietrich Rothenbacher
    • 2
  • Jens Huober
    • 1
  1. 1.Department of Gynecology and ObstetricsUniversity Hospital Ulm, University of UlmUlmGermany
  2. 2.Institute of Epidemiology and Medical BiometryUlm UniversityUlmGermany
  3. 3.Institute of PathologyUniversity Hospital UlmUlmGermany
  4. 4.Department of Gynecology and ObstetricsDiakonieklinikumSchwäbisch-HallGermany
  5. 5.Department of Gynecology and ObsteKliniken OstalbMutlangenGermany
  6. 6.Department of Gynecology and ObstetricsSanaklinikumBiberachGermany
  7. 7.Department of Gynecology and ObstetricsHospital MemmingenMemmingenGermany
  8. 8.Department of Gynecology and ObstetricsHospital EsslingenEsslingen am NeckarGermany
  9. 9.Department of Gynecology and ObstetricsHospital EichertGöppingenGermany
  10. 10.Department of Gynecology and ObstetricsHospital KemptenKemptenGermany
  11. 11.Department of Gynecology and ObstetricsAmper HospitalDachauGermany
  12. 12.Comprehensive Cancer CenterUniversity Hospital UlmUlmGermany

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