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

NCT02600065 | Completed

• 1 other identifier: GLIO-CMV-01
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

Cytomegalovirus Infections

Outcome Measures

Primary Outcomes (1)

• Change of CMV status during radio(chemo)therapy (RCT)

  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.

  up to day 45 after start of Radiotherapy

Secondary Outcomes (1)

• Change of circulating immune cells of treated patients by deep immunophenotyping.

  up to month 6 after the start of Radiotherapy

Study Arms (1)

Study cohort

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.

Other: Blood draw and MRI

Interventions

Blood draw and MRI OTHER

The study is observational. 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.

Study cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with brain tumours (glioblastoma or anaplastic astrocytoma Patients with brain metastases from diagnosed primary tumours

You may qualify if:

• 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.) \[brain tumors\]

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

Departement of Radiation Oncology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität erlangen-Nürnberg

Erlangen, Bavaria, 91054, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood for CMV status analysis blood for immunophenotyping serum plasma

MeSH Terms

Conditions

Cytomegalovirus Infections

Interventions

Blood Specimen Collection; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Spectrum Analysis; Chemistry Techniques, Analytical

Study Officials

• Rainer Fietkau, Prof.

  Department of Radiation Oncology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2015
• First Posted: November 9, 2015
• Study Start: November 1, 2014
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: February 16, 2023

Record last verified: 2021-04

Locations

DE (1)