BOOG
C.P. Schröder, G.S. Sonke, J.W.M. Martens, J. Wesseling
J.M. Rademaker-Lakhai, Gertruud Bakker (projectmedewerker)
BOOG Study Center inflame@boogstudycenter.nl phone: 088 – 234 6730
Not applicable
IKNL / Centrum zelf
Alpe d’HuZes
On the 29th of August 2015 the METC Groningen judged that this study is not applicable to WMO registration.
This nationwide study is a multicentre, prospective, observational and non-interventional study.
The main objective is to initiate a Dutch IBC registry for nationwide prospective clinical data and tissue collection, to improve general IBC awareness, and identify relevant molecular IBC characteristics to support an IBC specific intervention. Ultimately, this can contribute to improved outcome in IBC patients, and may potentially serve as example for future BC research in increasingly small subgroups. Secondary objectives are:- to assess current treatment and outcome of IBC in the Netherlands- to assess pathological and molecular IBC tissue characteristics in the Netherlands in relation to outcome.
The main endpoint in this observational study is to set up a registration system and collection of blood and tumor tissue of IBC patients in the Netherlands. Main study parameters will focus on clinical-, pathological- and molecular IBC characteristics, information regarding current treatments, and outcome in IBC patients.
In order to be eligible to participate in this study, a subject must meet all of the following criteria: – Gender: female- Diagnosis: primary IBC (all stages of the disease)- Age: ≥18 years old at time of diagnosis- Mental competence and understanding of the Dutch language are required. A potential subject being incapacitated or for any reason unable to provide informed consent will be excluded from participation in this study.
