PROSPECTIVE EVALUATION OF SERUM MALDI TOF MS PROTEOMIC PROFILE PREDICTIVE OF OUTCOME IN PATIENTS WITH GLIOBLASTOMA MULTIFORME TREATED WITH STANDARD TREATMENT STRATIFIED ACCORDING TO MGMT - ND

Conditions: patients affected by GBM
MedDRA version: 9.1Level: LLTClassification code 10018337

Registration Number: EUCTR2009-013662-33-IT

Lead Sponsor: FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

-C.I. firmato orima di sottoporsi a qualsiasi procedura;eta` compresa tra i 18 e i 70 anni; nuova diagnosi istologica di GBM; etc.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patient who can not comply with planned protocols procedures
Prior chemotherapy within the last 5 years
Prior RT of the head
Receiving concurrent investigational agents or has received an investigational agent
Prior anti-angiogenic therapy
Placement of Gliadel? wafer at surgery
Planned surgery for other diseases
History of malignancy. Subjects with curatively treated cervical carcinoma in situ or basal cell carcinoma of the skin, or subjects who have been free of other malignancies for more than 5 years are eligible for this study
Any uncontrolled intercurrent illness (e.g. high blood pressure, unstable angina, serious cardiac arrhythmia, diabetes ), also including severe infection, which may jeopardize the ability of the subject to receive the procedures outlined in this protocol with reasonable safety
Subject is pregnant (positive pregnancy test [serum -HCG] at screening), or is currently breast-feeding
Any psychological, familiar, sociological, legal or geographical state that could potentially interfere with the study protocol compliance; these conditions should be evaluated before patients enrolment

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: to identify a serum proteomic profile in patients with newly diagnosed glioblastoma multiforme treated with standard therapy.;Secondary Objective: to identify a serum proteomic profile in patients with newly diagnosed glioblastoma multiforme treated with standard therapy.;Primary end point(s): Correlation between proteomic profile and outcome, in terms of PFS and OS of patients with GBM treated with standard therapy

Secondary Outcome Measures