Immunophenotyping From Blood of Patients With Malignant Gliomas

NCT02022384 | Completed

• 1 other identifier: IMMO-GLIO 01
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Anaplastic Astrocytoma; Glioblastoma Multiforme

Keywords

Malignant glioma; Anaplastic astrocytoma; Glioblastoma multiforme; Immune; Immunophenotyping; Immune cells; activation state; Quality of live; translational research

Outcome Measures

Primary Outcomes (1)

• immunological state of patients comprising number, type and activation state of immune cells, cytokines and danger signals from peripheral blood

  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 Outcomes (7)

• Acquisition of toxicities according to Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0

  patients will be followed for the duration of therapy and follow-up until recurrence, an expected average of 6 months

• documentation of medication

  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

  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)

  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

  patients will be followed for the duration of therapy and follow-up until recurrence, an expected average of 6 months

Study Arms (1)

study patients

Blood sample and life quality questionnaires

Other: Blood sample and life quality questionnaires

Interventions

Blood sample and life quality questionnaires OTHER

Blood will be drawn at distinct time points during and after radio(chemo)therapy

study patients

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 primary diagnosed glioblastoma multiforme or anaplastic astrocytoma

You may qualify if:

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

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

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

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

Erlangen, BAY, 91054, Germany

Location

Related Publications (1)

• Ruhle PF, Goerig N, Wunderlich R, Fietkau R, Gaipl US, Strnad A, Frey B. Modulations in the Peripheral Immune System of Glioblastoma Patient Is Connected to Therapy and Tumor Progression-A Case Report from the IMMO-GLIO-01 Trial. Front Neurol. 2017 Jun 23;8:296. doi: 10.3389/fneur.2017.00296. eCollection 2017.

  PMID: 28690586 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum, plasma

MeSH Terms

Conditions

Astrocytoma; Glioblastoma; Glioma

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• 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

  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: December 13, 2013
• First Posted: December 27, 2013
• Study Start: December 1, 2013
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2022
• Last Updated: February 16, 2023

Record last verified: 2023-02

Locations

DE (1)