Studieoverzicht - 2014-05 INFLAME

 
Number 2014-05 INFLAME
Nickname INFLAME
Status Follow up Date: 06-02-2015
Inclusion closed 31-12-2018
Other study number(s)
Participating parties/groups
Full title INFLAME: Towards optimal treatment of inflammatory breast cancer patients
Phase and type This nationwide study is a multicentre, prospective, observational and non-interventional study
Age ≥ 18 years old at time of diagnosis
Menopausal status Not applicable
Indication Data registration
Subindication Not applicable
Target sample size 200
Actual accrual 125 Date: 31-12-2018
Estimated study completion date 31-12-2018
CCMO approval Not applicable Date: Nr:
EudraCT nr.
Trial Register Nummer is aangevraagd
METC approval Not applicable Date: METC: Universitair Medisch Centrum Groningen Nr:
Amendments No Date:
KWF-CKS approval Date: Nr:
News item
Website
Sponsor BOOG
Principal Investigator(s) C.P. Schröder, G.S. Sonke, J.W.M. Martens, J. Wesseling
Study manager J.M. Rademaker-Lakhai, Gertruud Bakker (projectmedewerker)

Central datamanagement and randomization BOOG Study Center
inflame@boogstudycenter.nl
phone: 088 - 234 6730
Monitoring Not applicable
Local datamanagement IKNL / Centrum zelf
Funding Logo Alpe dHuzes.jpgAlpe d'HuZes
Extra On the 29th of August 2015 the METC Groningen judged that this study is not applicable to WMO registration.

Design:

This nationwide study is a multicentre, prospective, observational and non-interventional study.

 

Objectives:

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.

Endpoints:

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.

Main eligibility criteria:

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.

Documents (protected):
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