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Immunophenotyping From Blood of Patients With Malignant Gliomas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02022384
Recruitment Status : Active, not recruiting
First Posted : December 27, 2013
Last Update Posted : April 27, 2021
Sponsor:
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School

Brief Summary:
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.

Condition or disease Intervention/treatment
Anaplastic Astrocytoma Glioblastoma Multiforme Other: Blood sample and life quality questionnaires

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.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Immunophenotyping From Blood From Patients With Glioblastoma and Anaplastic Astrocytoma Before and During Chemoradiation as Well as During Adjuvant Chemotherapy
Actual Study Start Date : December 2013
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022


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




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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

  6. overall survival [ Time Frame: patients will be followed for the duration of therapy and follow-up until recurrence, an expected average of 6 months ]
  7. 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 ]

Biospecimen Retention:   Samples With DNA
whole blood, serum, plasma


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with primary diagnosed glioblastoma multiforme or anaplastic astrocytoma
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02022384


Locations
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Germany
Departement of Radiation Oncology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität erlangen-Nürnberg
Erlangen, BAY, Germany, 91054
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Investigators
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Principal Investigator: Rainer Fietkau, Prof. Department of Radiation Oncology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg
Principal Investigator: Udo S Gaipl, Prof. Department of Radiation Oncology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT02022384    
Other Study ID Numbers: IMMO-GLIO 01
First Posted: December 27, 2013    Key Record Dates
Last Update Posted: April 27, 2021
Last Verified: April 2021
Keywords provided by University of Erlangen-Nürnberg Medical School:
Malignant glioma
Anaplastic astrocytoma
Glioblastoma multiforme
Immune
Immunophenotyping
Immune cells
activation state
Quality of live
translational research
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue