Clinical trial · Interventional
Prospective Evaluation of T-cell Immune Status in Patients With Newly Diagnosed High Grade Gliomas
NCT02041611CI-TRIAL-00033462completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
The primary goal of this study is evaluate T cell immune status and immune reconstitution and the association with specific cytokines in patients with newly diagnosed HGGs undergoing the standard RT/TMZ and adjuvant TMZ.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| High Grade Glioma | High-Grade Glioma, NOS | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood collections | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Standard Care Pts Eval of T-Cell Immune Status
- description
- Pts undergoing standard radiation/TMZ and adjuvant TMZ will have blood collections at 6 different time points throughtout their treatment to evaluate T Cell changes
- interventionNames
- Procedure: Blood collections
Primary outcomes (1)
- measure
- Changes in T Cell subtypes and cytokines as a function of treatment
- timeFrame
- 6 time points in pts undergoing standard RT/TMZ and adjuvant TMZ
- description
- baseline approx 6wks approx 10wks aprox 18wks approx 26wks 3 months after last cycle of TMZ
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients must be at least 18 years of age. 2. Patients must have histologically confirmed new diagnosed high grade glioma by pathology (WHO grade III and IV). 3. Patients proposed post-operative treatment plan must include standard radiation and temozolomide. 4. Patients must have a Karnofsky performance status ≥ 60% (i.e. the patient must be able to care for himself/herself with occasional help from others). 5. Patients must be able to provide written informed consent. 6. Steroid use is allowed. Exclusion Criteria: 1\. Patients with HIV are excluded.
References
Publications (0)
Data not yet available
No reference posted for this study.