Department of Gynecology and Obstetrics, University Hospital Ulm, University of Ulm, Prittwitzstr. 43, 89075, Ulm, Germany.
Institute of Epidemiology and Medical Biometry, Ulm University, Ulm, Germany.
Arch Gynecol Obstet. 2020 Jan;301(1):273-281. doi: 10.1007/s00404-019-05395-3. Epub 2019 Nov 28.
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 pellets.
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.
大型转化研究项目可以通过探索分子生物学、免疫学方法和鉴定新的预后和预测因素来促进癌症治疗的进一步进展。因此，BRandOBio 项目将一个临床注册处与一个生物库结合起来，该生物库包含肿瘤和液体活检。此外，还前瞻性地收集了包括原发性新诊断乳腺癌或卵巢癌、其他罕见恶性卵巢肿瘤或妊娠滋养细胞疾病患者的社会人口统计学、环境和生活方式因素。
目标人群包括德国的“阿尔布-阿尔高-博登湖地区”，该地区构成了乌尔姆大学医院及其附属学术中心和私人诊所的服务区域。在未来几年内，将从 4000 多名患者中获取临床数据，结合原发肿瘤组织样本和纵向反复采集的血液样本[治疗前、6 个月（高危情况）、12、36 和 60 个月以及复发时]。为乌尔姆大学医院的患者和八个选定的外部站点提供标准化问卷，以评估生活方式和癌症风险因素。同时，储存石蜡包埋的肿瘤样本和液体活检样本将允许进行转化研究项目，例如研究循环 DNA 和来自细胞沉淀的种系 DNA。
从 2016 年 1 月开始，乌尔姆大学医院开始招募患者，2017 年 3 月，另外 19 个外部站点开始招募患者。截至 2019 年 9 月 15 日，已招募了 2151 名新诊断癌症患者（2044 名乳腺癌；107 名卵巢癌）。几乎所有患者都提供了生物样本（肿瘤和液体活检），约 80%的患者返回了标准化问卷。经过 1 年的随访，超过 80%的参与患者提供了血液样本。
BRandO BIO 研究是一项大型前瞻性队列研究，在德国西南部一个明确界定的地理区域内，对妇科癌症患者进行综合全面的生物库评估和社会人口统计学及生活方式因素评估。持续高比例的患者招募和超过 80%的返回问卷率以及重复采血率表明，BRandO 研究方案的高接受度和项目的可行性。
