The Clinical Trials Support Unit (CTSU) is an operational support unit for academic clinical research into all types of cancer. Certain scientific questions of interest to patients can only be understood by means of academic research. This academic research must comply with all quality standards and legal and regulatory requirements applicable to research. It must also be carried out efficiently.
It is for all these reasons that the Institut Bordet, in a desire to develop and encourage such research, decided to create the CTSU. This unit within the Institution brings together the skills and resources needed to conduct high-level research. The CTSU team is responsible for responding to research questions and evaluating the benefits and risks of drugs and procedures, while always ensuring that the patients participating in the clinical studies are adequately protected.
The CTSU is responsible for the operational management of the clinical studies promoted by the Institut Bordet. It can also provide its services to external promoters, both academic and private (such as pharmaceutical or biotechnology firms).
The CTSU works in close collaboration with the Institut’s medical and scientific team and offers a professional operational structure to support scientific creativity.
The unit provides research support in the following fields:
- project management
- data management
- regulatory matters
- drug safety
- quality management
- translational research
- medical imaging data management via the ORILaB platform
The CTSU regularly organises internal training and seminars on the management of clinical studies, including Good Clinical Practice. This training is designed for those involved in research projects, including research physicians wishing to develop their clinical study conduct skills.
The CTSU also welcomes trainees wishing to gain experience and specific skills in the management of clinical studies: project management, monitoring, regulatory matters and all other activities carried out by the CTSU. These placements allow trainees to familiarise themselves with the conduct of high-level clinical studies in an academic environment.
Applications to : email@example.com
Tumor-Infiltrating Lymphocytes in Patients Receiving Trastuzumab/Pertuzumab-Based Chemotherapy: A TRYPHAENA Substudy.
Authors : Ignatiadis M, Van den Eynden G, Roberto S, Fornili M, Bareche Y, Desmedt C, Rothé F, Maetens M, Venet D, Holgado E, McNally V, Kiermaier A, Savage HM, Wilson TR, Cortes J, Schneeweiss A, Willard-Gallo K, Biganzoli E, Sotiriou C
Year : 2019
Journal : J Natl Cancer Inst
Volume : 111
Pages : 69-77
Prognostic value of adipose tissue and muscle mass in advanced colorectal cancer: a post hoc analysis of two non-randomized phase II trials.
Authors : Charette N, Vandeputte C, Ameye L, Bogaert CV, Krygier J, Guiot T, Deleporte A, Delaunoit T, Geboes K, Van Laethem JL, Peeters M, Demolin G, Holbrechts S, Flamen P, Paesmans M, Hendlisz A
Year : 2019
Journal : BMC Cancer
Volume : 19
Pages : 134
Combining 18F-FDG PET/CT-based Metabolically Active Tumor Volume and Circulating Cell-free DNA Significantly Improves Outcome Prediction in Chemorefractory Metastatic Colorectal Cancer.
Authors : Woff E, Kehagias P, Vandeputte C, Ameye L, Guiot T, Paesmans M, Hendlisz A, Flamen P
Year : 2019
Journal : J Nucl Med
Circulating tumor DNA in HER2 amplified breast cancer: a translational research substudy of the NeoALTTO phase 3 trial.
Authors : Rothé F, Silva MJ, Venet D, Campbell C, Bradbury I, Rouas G, de Azambuja E, Maetens M, Fumagalli D, Rodrik-Outmezguine V, Di Cosimo S, Rosa DD, Chia SK, Wardley AM, Ueno T, Janni W, Huober J, Baselga J, Piccart-Gebhart M, Loi S, Sotiriou C, Dawson SJ, Ignatiadis M
Year : 2019
Journal : Clin Cancer Res
Cardiac biomarkers for early detection and prediction of trastuzumab and/or lapatinib-induced cardiotoxicity in patients with HER2-positive early-stage breast cancer: a NeoALTTO sub-study (BIG 1-06).
Authors : Ponde N, Bradbury I, Lambertini M, Ewer M, Campbell C, Ameels H, Zardavas D, Di Cosimo S, Baselga J, Huober J, Izquierdo M, Fumagalli D, Bozovic-Spasojevic I, Maetens M, Harbeck N, Pusztai L, Berghorn M, Im YH, Borrego MR, Chen DR, Rodeheffer R, Piccart-Gebhart M, Suter T, de Azambuja E
Year : 2018
Journal : Breast Cancer Res Treat
Volume : 168(3)
Pages : 631-638