Analysis of CMV Infections in Patients With Brain Tumors or Brain Metastases During and After Radio(Chemo)Therapy (GLIO-CMV-01)

University of Erlangen-Nürnberg Medical School

Status: Completed

Conditions: Cytomegalovirus Infections

Treatments: Other: Blood draw and MRI

Study type: Observational

Funder types: Other

Identifiers

NCT02600065

GLIO-CMV-01

Details and patient eligibility

About

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.

Enrollment: 350 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• brain tumours (glioblastoma or anaplastic astrocytoma)
• brain metastases from diagnosed primary tumours
• legal age
• planned chemoradiation and adjuvant chemotherapy [metastases]
• planned chemoradiation and adjuvant chemotherapy with temodal (according to Stupp et. al.) [brain tumors]

Exclusion criteria

• fertile patients who refuse effective contraception during study treatment
• persistent drug and/or alcohol abuse
• patients not able or willing to behave according to study protocol
• patients in care
• patients that are not able to speak German
• patients with claustrophobia
• patients with artificial joint or any metal parts in the body
• patients with pacemakers

Trial design

350 participants in 1 patient group

Study cohort

Description:

All patients who are suffering from brain tumor of brain metastases and are willing to participate. The treatment-plan of the underlying disease remained unchanged. Blood draw and MRI from patients at several time points during and after radio(chemo)therapy.

Treatment:

Other: Blood draw and MRI