Clinical trial · Observational
Immunophenotyping From Blood of Patients With Malignant Gliomas
Immunophenotyping From Blood From Patients With Glioblastoma and Anaplastic Astrocytoma Before and During Chemoradiation as Well as During Adjuvant Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anaplastic Astrocytoma | Anaplastic Astrocytoma | CURATED_BROADER | 0.80 |
| Glioblastoma Multiforme | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood sample and life quality questionnaires | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- study patients
- description
- Blood sample and life quality questionnaires
- interventionNames
- Other: Blood sample and life quality questionnaires
Primary outcomes (1)
- measure
- immunological state of patients comprising number, type and activation state of immune cells, cytokines and danger signals from peripheral blood
- timeFrame
- patients will be followed for the duration of therapy and follow-up until recurrence, an expected average of 6 months
- description
- 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 outcomes (7)
- measure
- Acquisition of toxicities according to Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDRuhle 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