From prospective biobanking to precision medicine: BIO-RAIDs – an EU study protocol in cervical cancer

BMC Cancer

Study Protocol

Marina Popovic¹  Sanne Samuels²  Gemma Kenter²  Roman Rouzier³  Lisa Belin³  Ksenia Bagrintseva³  Maud Kamal³  Patricia Tresca³  Philippe Hupé⁴  Suzy Scholl⁵  Charlotte Ngo⁶  Andrea Slocker⁷  Eric Deutsch⁷  Nina Samet⁸  Heiko von der Leyen⁹ 

[1] Department of Gynecology, Institut of Oncology of Vojvodina (IOV), Put Doktora Goldmana 4, 21204, Sremska Kamenica, Serbia;Department of Gynecology, Netherlands Cancer Institute – Antoni van Leeuwenhoek (NKI-AVL), P.O. Box 90203, 1006 BE, Amsterdam, The Netherlands;Department of Medical Oncology, Institut Curie, 25 Rue d’Ulm, 75005, Paris, France;Department of Medical Oncology, Institut Curie, 25 Rue d’Ulm, 75005, Paris, France;INSERM U900, Paris, France;Mines ParisTech, Fontainebleau, France;CNRS UMR 144, Paris, France;Department of Medical Oncology, Institut Curie, 25 Rue d’Ulm, 75005, Paris, France;Institut Curie, 26 rue d’Ulm 75248, Cedex 05, Paris, France;Department of Medical Oncology, Institut Curie, 25 Rue d’Ulm, 75005, Paris, France;Present address: Department of gynecological and breast oncological surgery, Hôpital Européen Georges Pompidou, 20 rue Leblanc, 75015, Paris, France;Department of Radiation Oncology, Institut Gustave Roussy (IGR), 114 Rue Edouard-Vaillant, 94805, Villejuif Cedex, France;Department of Radiology Gynecology, Institute of Oncology of Republic of Moldova, str. N. Testemiţanu 30, MD-2025, Chişinău, Republica Moldova;Hannover Clinical Trial Center (HCTC) GmbH, Carl-Neuberg-Str.1, 30625, Hannover, Germany;

关键词: Prospective European biobanking study;    Precision medicine;    Molecular profiling;    Cervical cancer;    Next generation sequencing;    Reverse phase protein array;    Tumor micro environment;    Targeted therapy;    Patient stratification;    International trial;    Clinical trial operations;    Quality control of pelvic radiotherapy;    Biobanking;    HPV typing;   

DOI  :  10.1186/s12885-015-1801-0

 received in 2015-08-06, accepted in 2015-10-16,  发布年份 2015

来源: Springer

【 摘 要 】

BackgroundCervical cancer (CC) is -second to breast cancer- a dominant cause of gynecological cancer-related deaths worldwide. CC tumor biopsies and blood samples are of easy access and vital for the development of future precision medicine strategies.DesignBIO-RAIDs is a prospective multicenter European study, presently recruiting patients in 6 EU countries. Tumor and liquid biopsies from patients with previously non-treated cervical cancer (stages IB2-IV) are collected at defined time points. Patients receive standard primary treatment according to the stage of their disease. 700 patients are planned to be enrolled. The main objectives are the discovery of -dominant molecular alterations, -signalling pathway activation, and -tumor micro-environment patterns that may predict response or resistance to treatment. An exhaustive molecular analysis is performed using 1° Next generation sequencing, 2° Reverse phase protein arrays and 3° Immuno-histochemistry.DiscussionThe clinical study BIO-RAIDs is activated in all planned countries, 170 patients have been recruited till now. This study will make an important contribution towards precision medicine treatments in cervical cancer. The results will support the development of clinical practice guidelines for cervical cancer patients to improve their prognosis and their quality of life.Trial registrationClinicaltrials.gov: NCT02428842, registered 10 February 2015.

【 授权许可】

CC BY   
© Ngo et al. 2015