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 Gregorio, 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
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.
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
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.
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.
De Gregorio A, Nagel G, Möller P, Rempen A, Schlicht E, Fritz S,
Flock F, Kühn T, Thiel F, Felberbaum R, Ebner F, De Gregorio N,
Friedl T W P, Wiesmüller L, Kuhn P, Schmitt M, Janni W,
Rothenbacher D, Huober J. 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. Arch Gynecol Obstet 2019; 301:273-281.
journal paper/review (English)
date of publishing
Arch Gynecol Obstet (301/1)
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