Immunophenotyping From Blood of Patients With Malignant Gliomas

February 15, 2023 updated by: University of Erlangen-Nürnberg Medical School

Immunophenotyping From Blood From Patients With Glioblastoma and Anaplastic Astrocytoma Before and During Chemoradiation as Well as During Adjuvant Chemotherapy

In this explorative study immunological changes during tumor therapy will be analyzed in patients with malignant glioma. Immunophenotyping before and during therapy is used as analysis method. Thereby immune cells are quantitatively and qualitatively detected from patient's blood at continuous time points. Additionally relevant mediators like cytokines, danger signals and chemokines are analyzed by other methods. Obtained results may give information about the effects of therapy on immunological processes and immune cells and may help to find immunological based predictive or prognostic tumor markers and to define time points for including additional immune therapy in the future.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients with malignant glioma generally have a bad prognosis. To improve patients' situation new therapy options as well as new possibilities to determine prognosis and prediction more precisely are needed. One approach is the targeted activation of the immune system to recognize and eliminate tumor cells. Due to cerebral tumors the brain is no immune privileged organ anymore, so that immune cells may pass the haemato-encephalic barrier to attack tumor cells. This study aims to offer valuable clues about how the immune system is influenced by standard therapies (radiotherapy and chemotherapy). Just with the background knowledge of immune mechanisms and influencing factors by tumor therapy, an effective anti-tumor response can systematically be induced by modulating immune therapy. To analyze immunological changes, immunophenotyping by flow cytometry is performed with blood from patients with malignant gliomas during their therapy concluding chemoradiation and chemotherapy alone. Count, class and activation status of immune cells are detected by flow cytometry. Together with additional analysis methods, information about immunological mediators like cytokines, chemokines and danger signals can be received. For these purposes serum and plasma are generated from blood samples and stored for prospective questions. The explorative determined results may also help to discover new, immunological based, prognostic or predictive tumor markers.

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • BAY
      • Erlangen, BAY, Germany, 91054
        • Departement of Radiation Oncology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität erlangen-Nürnberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with primary diagnosed glioblastoma multiforme or anaplastic astrocytoma

Description

Inclusion Criteria:

  • patients with glioblastoma or anaplastic astrocytoma
  • legal age
  • planned chemoradiation and adjuvant chemotherapy (according to Stupp et. al.)

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
study patients
Blood sample and life quality questionnaires
Other: Blood sample and life quality questionnaires
Blood will be drawn at distinct time points during and after radio(chemo)therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
immunological state of patients comprising number, type and activation state of immune cells, cytokines and danger signals from peripheral blood
Time Frame: patients will be followed for the duration of therapy and follow-up until recurrence, an expected average of 6 months

Time points for blood sample collections:

Before start of chemoradiation (RCT). In 3th week of RCT. At last day of RCT. At the beginning of chemotherapy (CT) (about 4 weeks after RCT). During CT each three to four weeks. At follow-up visits each one to three months. During recurrence therapy.
patients will be followed for the duration of therapy and follow-up until recurrence, an expected average of 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acquisition of toxicities according to Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0
Time Frame: patients will be followed for the duration of therapy and follow-up until recurrence, an expected average of 6 months
patients will be followed for the duration of therapy and follow-up until recurrence, an expected average of 6 months
documentation of medication
Time Frame: patients will be followed for the duration of therapy and follow-up until recurrence, an expected average of 6 months
patients will be followed for the duration of therapy and follow-up until recurrence, an expected average of 6 months
Acquisition of changes in imaging
Time Frame: patients will be followed for the duration of therapy and follow-up until recurrence, an expected average of 6 months
patients will be followed for the duration of therapy and follow-up until recurrence, an expected average of 6 months
Acquisition of life quality according to quality of life questionnaire (QLQ) (EORTC QLQ -BN20)
Time Frame: patients will be followed for the duration of therapy and follow-up until recurrence, an expected average of 6 months
patients will be followed for the duration of therapy and follow-up until recurrence, an expected average of 6 months
correlation of immunological parameters with clinical data
Time Frame: patients will be followed for the duration of therapy and follow-up until recurrence, an expected average of 6 months
Correlation with results of immunophenotyping, possibly definition of medically relevant markers
patients will be followed for the duration of therapy and follow-up until recurrence, an expected average of 6 months
overall survival
Time Frame: patients will be followed for the duration of therapy and follow-up until recurrence, an expected average of 6 months
patients will be followed for the duration of therapy and follow-up until recurrence, an expected average of 6 months
progression free survival
Time Frame: patients will be followed for the duration of therapy and follow-up until recurrence, an expected average of 6 months
patients will be followed for the duration of therapy and follow-up until recurrence, an expected average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Erlangen-Nürnberg Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2013

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

December 13, 2013

First Submitted That Met QC Criteria

December 20, 2013

First Posted (Estimate)

December 27, 2013

Study Record Updates

Last Update Posted (Actual)

February 16, 2023

Last Update Submitted That Met QC Criteria

February 15, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMMO-GLIO 01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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