NCT02751138

Brief Summary

Glioblastoma multiforme (GBM) is the most common primary brain tumor in adults. Despite intensive research efforts and a multimodal management that actually consists of surgery, radiotherapy and chemotherapy with temozolomide, the prognosis is dismal. The aim of the current observational study is to determine immune phenotypes in individual patients with GBM at the time of diagnosis and to correlate tumor size, location (imaging), tumor properties (isocitrate dehydrogenase - 1 (IDH-1), o6-methylguanine-DNA-methyltransferase (MGMT), epidermal growth factor receptor (EGFR) mutation status, etc.) with clinical data, such as progression free and overall survival, Karnofsky index (progression free survival (PFS),overall survival (OS), Karnofsky score( KFS)), with blood immune phenotypes, biomarkers, and immune histochemical results of tumor infiltrating lymphocytes, macrophages, myeloid derived suppressor cells (MDSC), etc.. The different immunological phenotypes could predict a positive response to specific immunological therapeutic strategies and select the individual therapeutic plan for an individual GBM patient.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 19, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 26, 2016

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

May 16, 2023

Status Verified

May 1, 2023

Enrollment Period

6.8 years

First QC Date

April 19, 2016

Last Update Submit

May 14, 2023

Conditions

Glioblastoma Multiforme

Keywords

Immune phenotypeCytokinesGenetic aberrationOverall survivalProgression free survival

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    3 months

Secondary Outcomes (2)

  • Progression free survival

    3 months

  • Karnofsky performance score

    3 months

Study Arms (2)

Isocitrate dehydrogenase - 1 mutated

Immunophenotype of Glioblastoma and correlation with outcome

Procedure: Surgery

Isocitrate dehydrogenase - 1 wild type

Immunophenotype of Glioblastoma and correlation with outcome

Procedure: Surgery

Interventions

SurgeryPROCEDURE

Tumor resection

Isocitrate dehydrogenase - 1 mutatedIsocitrate dehydrogenase - 1 wild type

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult glioblastoma multiforme

You may qualify if:

  • adult glioblastoma multiforme

You may not qualify if:

  • pregnancy, unable to give consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurosurgery

Ulm, 89081, Germany

Location

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral Blood Mononuclear Cell (PBMC), Plasma, Tumor tissue, DNA, RNA, miRNA

MeSH Terms

Conditions

Glioblastoma

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 19, 2016

First Posted

April 26, 2016

Study Start

March 1, 2016

Primary Completion

December 1, 2022

Study Completion

January 1, 2023

Last Updated

May 16, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will share

Immune phenotypes of glioma patients included and clinical follow-up

Locations

DE(1)