A prospective multicenter study on bladder cancer: the COBLAnCE cohort

BMC Cancer

Study Protocol

François Radvanyi¹  Julia Bonastre²  Karine Groussard³  Simone Benhamou⁴  Thierry Lebret⁵  Yves Allory⁶ 

[1] CNRS, UMR144, Equipe Labellisée par la Ligue Nationale contre le Cancer, Paris, France;Institut Curie, PSL Research University, Paris, France;Gustave Roussy, Service de biostatistique et d’épidémiologie, Villejuif, France;CESP Centre for Research in Epidemiology and Population Health, INSERM U1018, University Paris-Sud, UVSQ, Université Paris-Saclay, Villejuif, France;INSERM, UMR 946, Genetic Variation and Human Diseases Unit, 27 rue Juliette Dodu, 75010, Paris, France;Université Paris Diderot, Sorbonne Paris Cité, Institut Universitaire d’Hématologie, Paris, France;INSERM, UMR 946, Genetic Variation and Human Diseases Unit, 27 rue Juliette Dodu, 75010, Paris, France;Université Paris Diderot, Sorbonne Paris Cité, Institut Universitaire d’Hématologie, Paris, France;Gustave Roussy, Service de biostatistique et d’épidémiologie, Villejuif, France;Service d’urologie et de transplantation rénale, Hôpital Foch, Suresnes, France;UFR des sciences de la santé Simone Veil, Université de Versailles-Saint-Quentin-en-Yvelines, Suresnes, France;Université Paris-Est, Créteil, France;INSERM, UMR 955, Créteil, France;Département de pathologie, APHP, Hôpital Henri-Mondor, Créteil, France;

关键词: Bladder cancer;    Cohort study;    Biobanks;    Gene-environment interactions;    Molecular classification;    Biomarkers;    Healthcare resource use;    Quality of life;    Outcomes;   

DOI  :  10.1186/s12885-016-2877-x

 received in 2016-03-22, accepted in 2016-10-24,  发布年份 2016

来源: Springer

【 摘 要 】

BackgroundBladder cancer is a very heterogeneous disease as regards natural history. Environmental exposures, constitutional genetic and/or epigenetic background may affect not only the likelihood of bladder tumor occurrence, but also the histologic type of cancer and its outcome. Currently, only a few data are available to study the prognostic role of genetic and environmental factors. Likewise, data on the economic burden of bladder cancer and the longitudinal impact of the disease and the treatments on patient quality of life are scarce.MethodsCOBLAnCE is a large French-based clinical cohort study on bladder cancer. Newly diagnosed patients are enrolled prospectively in 12 public hospitals and 5 private for profits hospitals. The target sample size is 2,000 patients. All patients are to be followed for 6 years. Information on patient characteristics and lifestyle is collected during a face-to-face interview at enrollment. Clinical information on disease presentation, diagnosis, and treatment is extracted from medical records for the primary tumor and for all subsequent local and distant recurrences. Quality of life and resource use is collected at recruitment and during follow-up. In parallel, 4 types of biological samples (blood, tumor tissue, urine and nail) are collected, at baseline and during follow-up. DNA, RNA and PBMLs are extracted from blood samples, DNA and RNA from stabilized urine, proteins from frozen urine, DNA, RNA and proteins from frozen tumor tissues, and DNA and RNA from formalin-fixed paraffin-embedded tumor tissues. All derived products are stored at −80 °C or in liquid nitrogen. Main endpoints are gene-environment interactions, molecular classification, biomarker discovery, therapeutic innovation, treatment patterns, healthcare resource use, bladder cancer outcomes and quality of life.DiscussionThe COBLAnCE cohort will provide considerable insight into the biology of bladder cancer and the mechanisms through which genetic and environmental factors may influence the prognosis. It may allow the discovery of emerging biomarkers. Finally, economic data will be useful for future cost-effectiveness studies of immunotherapy drugs or other therapeutics in bladder cancer.

【 授权许可】

CC BY   
© The Author(s). 2016