Primary: The major aim is to identify peptides naturally presented on glioblastoma tumors but not on healthy tissue to set up a glioblastoma specific database for potential application for immunotherapeutic aproaches.secondary: a protocol for tumor…
ID
Source
Brief title
Condition
- Nervous system neoplasms malignant and unspecified NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Mutated and non-mutated tumor-associated antigens in glioblastoma
Secondary outcome
EU harmonized procedures for imuunmonitoring.
A glioblastoma specific sHLA:peptidome.
Background summary
Glioblastoma is a fatal disease with a median survival of less than 1.5 years.
One novel promising approach in oncology is activation of the patient's own
immune system against the cancer by vaccinations to evoke an immune response
leading to elimination of the malignant cells.
Study objective
Primary: The major aim is to identify peptides naturally presented on
glioblastoma tumors but not on healthy tissue to set up a glioblastoma specific
database for potential application for immunotherapeutic aproaches.
secondary: a protocol for tumor infiltrating lymphocytes (TILs) extraction of
tumor samples of glioblastoma patients will be set up for use in later clinical
development. Moreover, the glioblastoma specific sHLA:peptidome will be
identified from plasma samples of patients for use as surrogate biomarker in
later clinical trials.
Study design
Patients will be informed both by personal communication about the study in
conjunction with an ordinary visit prior to surgery and in a written form.
At the day of surgery blood (20 ml) will be drawn for plasma sample
preparation, HLA typing and genomic analysis. Part of the tumor tissue that
has been removed during standard surgery will, if possible, be colected for
mutation, peptide presentation, proteomics analysis and TIL analysis.
2-12 weeks post surgery another blood sample (10 ml) will be drawn for plasma
sample preparation at a regular visit.
Study burden and risks
All blood samples will be drawn during routine visits of the patient within
standard therapy. venous bloodsampling may cause local pain or bruising.
No additional study specific risk will occur from tumor sample analysis, sinc
stumor analysis will be perfomed on tumor samples removed during routine
surgery
Albinusdreef 2
Leiden 2333ZA
NL
Albinusdreef 2
Leiden 2333ZA
NL
Listed location countries
Age
Inclusion criteria
Age: >= 18 years
• Unresected primary or recurrent brain tumor
• Haemoglobin >= 10 g/100 ml
• Able to understand the research and give written informed consent
Exclusion criteria
none
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL43349.058.13 |