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Immunophenotyping From Blood of Patients With Malignant Gliomas

U

University of Erlangen-Nürnberg Medical School

Status

Completed

Conditions

Glioblastoma Multiforme
Anaplastic Astrocytoma

Treatments

Other: Blood sample and life quality questionnaires

Study type

Observational

Funder types

Other

Identifiers

NCT02022384
IMMO-GLIO 01

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

50 participants in 1 patient group

study patients
Description:
Blood sample and life quality questionnaires
Treatment:
Other: Blood sample and life quality questionnaires

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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