Clinical Trial: Analysis of CMV Infections in Patients With Brain Tumors or Brain Metastases During and After Radio(Chemo)Therapy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Analysis of CMV Infections in Patients Suffering From Brain Tumors and Brain Metastases During and After Radio(Chemo)Therapy

Brief Summary: Radio(chemo)therapy is the standard therapy for both, brain tumors and brain metastases. Neurological decline is observed in these patients and tumor progression or radiotherapy side effects have been made responsible for this. However CMV encephalitis may also be a reason. Therefore the investigators aim to analyze the CMV status in patients during and after radio(chemo)therapy. It will be checked by CMV-DNA (PCR analysis) and CMV antibodies (IgG and IgM ELISA) in the blood of the patients. These findings will be correlated with changes in the brain, visualized by MRI. In addition a detailed immunophenotyping in the peripheral blood will be performed.

Detailed Summary:
Sponsor: University of Erlangen-Nürnberg Medical School

Current Primary Outcome: Change of CMV status during radio(chemo)therapy (RCT) [ Time Frame: up to day 45 after start of Radiotherapy ]

CMV infection will be monitored by virus analysis by an approved laboratory. The analyses were conducted at time points during and after RCT - before RT (day 0), during RT (dose halftime), end of RT (last day of RT), month 3 and 6 after completed RT. This scheme is repeated if patient receives additional RT for relapse treatment. The time points during RT were determined depending on the applied irradiation dose. For glioblastoma the halftime of RT is usually day 23 (received dose 30 Gy) and the end of therapy is usually day 45 (received dose 60 Gy). For cerebral metastases the halftime of the RT is usually day 8 (received dose 9 Gy) and day 16 at the end of therapy (received dose 18 Gy). However, the time points are strongly connected to the received dose.


Original Primary Outcome: Same as current

Current Secondary Outcome: Change of circulating immune cells of treated patients by deep immunophenotyping. [ Time Frame: up to month 6 after the start of Radiotherapy ]

Immunophenotyping of the patients. Detection of about 30 distinct immune sell (sub)types together with their activation markers.The analyses were conducted at time points during and after RCT - before RT (day 0), during RT (dose halftime), end of RT (last day of RT), month 3 and 6 after completed RT. This scheme is repeated if patient receives additional RT for relapse treatment. The time points during RT were determined depending on the applied irradiation dose. For glioblastoma the halftime of RT is usually day 23 (received dose 30 Gy) and the end of therapy is usually day 45 (received dose 60 Gy). For cerebral metastases the halftime of the RT is usually day 8 (received dose 9 Gy) and day 16 at the end of therapy (received dose 18 Gy). However, the time points are strongly connected to the received dose.


Original Secondary Outcome: Same as current

Information By: University of Erlangen-Nürnberg Medical School

Dates:
Date Received: October 23, 2015
Date Started: November 2014
Date Completion: November 2019
Last Updated: November 24, 2016
Last Verified: November 2016