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

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.

Appendix 1

Variable	Part of the required cancer documentation report
Date of birth	×
Gender	×
Date of death	×
Death caused by cancer	×
Primary tumor ICD-code	×
Primary tumor ICD-version	×
Primary tumor topography ICD-O	×
Primary tumor topography ICD-O-version	×
Tumor date of diagnosis	×
Tumor localisation (left/right)	×
Previous history of cancer	×
Menopausal status	×
Height (at time of first diagnosis)
Weight (at time of first diagnosis)
Localisation of distant metastases (primary)	×
Date of histological confirmation of distant metastases	×
Histology date	×
Histology internal registration number
Responsible Pathological Institute
Morphology-code	×
Morphology ICD-O-version	×
Grading	×
TNM_VERSION	×
TNM T-category	×
TNM N-category	×
TNM M-category	×
TNM L-category	×
TNM V-category	×
R-status	×
Number of removed lymph nodes	×
Number of positive lymph nodes	×
Number of removed sentinel lymph nodes	×
Number of positive sentinel lymph nodes	×
ER-IRS	×
ER—%
PgR-IRS	×
PgR—%
Her2Neu-score	×
FISH
Ki67
Invasive tumor size	×
DCIS tumor size	×
Date of surgery	×
OPS-code	×
OPS-version	×
Intention of surgery (curative, palliative, etc.)	×
Intention of radiotherapy	×
Start date of radiotherapy	×
Stop date of radiotherapy	×
Localization of radiotherapy (e.g., breast, chest wall)	×
With/without lymph node region	×
Side of radiotherapy (left/right)	×
Intention of systemic therapy	×
Type of systemic therapy	×
Start date of systemic therapy	×
Stop date of systemic therapy	×
Treatment protocol for systemic therapy	×
Systemic therapy agents	×
Date of assessment of current tumor status	×
Current tumor status	×
Current status primary tumor	×
Current status lymph nodes	×
Current status distant metastases	×
Localisation of distant metastases	×
Date of histological confirmation of distant metastases	×