Implementation of clinical trials for which the centre is the promoter.
Contacts
Head of department
Pathologies
- Tumeur de l’ovaire
- Tumeur du col de l’utérus ou de l’endomètre
- Tumeur de la prostate
- Tumeur du rein
- Tumeur du testicule
- Tumeur de la vessie
Services
- Oncologie gynécologique
- Oncologie urologique
- Recherche clinique
Membre de
- Inserm U 1086
- Cancéropôle Nord-Ouest
- Intergroupes nationaux de recherche clinique (GETUG, GINECO, Unicancer, AFSOS)
- Intergroupes internationaux (EORTC, GCIG)
- Sociétés savantes (ESMO, ESGO, ICCTF)
Domaines d’expertise
- Oncologie médicale (gynécologie et urologie)
- Recherche clinique
- Recherche en Sciences Humaines et Sociales (Qualité de vie, Après-cancer, Cognition)
Enseignement
- Centre François Baclesse : formation des internes en médecine, formation continue post-universitaire (EPU)
- UFR Santé de l’Université de Caen-Normandie : coordination de l’UE 9 (cancérologie)
Promotion manager
- Bénédicte Clarisse, PharmD, PhD
Project managers
- Jean-Michel Grellard
- Alexandra Leconte
Coordinating Clinical Research Assistant
- Marine Moreau
Biostatisticians
- Justine Lequesne, PhD
- Sophie Lefevre-Arbogast, PhD
Pharmacovigilance
- Marie Castera, PharmD
Activities
The CFB Clinical Research Department’s promotion unit ensures the design, implementation and coordination of clinical trials for which the centre is the promoter, in accordance with current regulations.
It ensures the submission of responses to calls for proposals and regulatory authorities (ANSM – French National Agency for Drug and Health Product Safety, Ethics Committees, CNIL – National Committee for Computer Processing and Liberties, etc.) relating to clinical trials proposed by the clinicians and carers at the CFB.
It watches over the safety of patients included in trials promoted by the CFB by ensuring appropriate vigilance, in accordance with applicable regulations.
Biostatisticians assist in the design of clinical trials, by defining the most adapted methodology. At the end of the study, they elaborate data analysis reports which enable the coordinating physician to valorise the results of research, in particular in the form of publications in scientific journals or during oral and written presentations during scientific conferences.
Our results
18 Studies promoted by the CFB open to inclusions in 2019
3 Projects selected following DGOS (healthcare offer directorate general) calls for proposals in 2019
2,633 Patients included in studies promoted by the CFB between 2014 and 2018
26 Publications resulting from promoted studies between 2014 and 2018
Projects selected following DGOS calls for proposals in 2019
| Acronym | Full title | Coordinating physician | Call for proposals |
|---|---|---|---|
| OLIGO-BM | Stereotactic radiotherapy in oligometastatic brain disease: Randomised phase III study, comparing hypofractionated stereotactic radiotherapy (310 Gy) with historic radiosurgery (120 to 25 Gy) including medico-economic evaluation. | Dr Dinu Stefan | PHRC-K (Hospital Clinical Research Programme) |
| NANOPRO | Re-irradiation by nanoparticles and hypofractionated proton therapy of relapsed pan-tumours: non-randomised phase II study | Dr Delphine Lerouge | PHRC-I (Hospital Clinical Research Programme) |
| ROBOCUP | Relevance of robot- or laser-assisted tongue base mucosectomy in association with unilateral amygdalectomy in the assessment of prevalent cervical adenopathies: randomised phase II study | Dr Vianney Bastit | PHRC-I (Hospital Clinical Research Programme) |
- At regional level: GIRCI-NO, CHU hospital Caen, Centre Henri Becquerel, Cancéropôle Nord-Ouest
- At national level: INCa, Unicancer, Ligue Nationale contre le Cancer, INSERM, CNRS, ARCAGY-GINECO, GFPC, IFCT, GORTEC, GETUG, ANOCEF, TUTHYREF, etc.