Anaplastic AstrocytomaNCT02022384
Immunophenotyping From Blood of Patients With Malignant Gliomas
An observational study of Anaplastic Astrocytoma and Glioblastoma Multiforme, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anaplastic Astrocytoma, Glioblastoma Multiforme
- What is being tested?
- Blood sample and life quality questionnaires
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2013to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with primary diagnosed glioblastoma multiforme or anaplastic astrocytoma
Who may be able to join
- patients with glioblastoma or anaplastic astrocytoma
- legal age
- planned chemoradiation and adjuvant chemotherapy (according to Stupp et. al.)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Departement of Radiation Oncology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität erlangen-Nürnberg
Erlangen, BAY, 91054
About this study
Official title: Immunophenotyping From Blood From Patients With Glioblastoma and Anaplastic Astrocytoma Before and During Chemoradiation as Well as During Adjuvant Chemotherapy
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.
Read the detailed description
Patients with malignant glioma generally have a bad prognosis. To improve patients' situation new therapy options as well as new possibilities to determine prognosis and prediction more precisely are needed. One approach is the targeted activation of the immune system to recognize and eliminate tumor cells. Due to cerebral tumors the brain is no immune privileged organ anymore, so that immune cells may pass the haemato-encephalic barrier to attack tumor cells. This study aims to offer valuable clues about how the immune system is influenced by standard therapies (radiotherapy and chemotherapy). Just with the background knowledge of immune mechanisms and influencing factors by tumor therapy, an effective anti-tumor response can systematically be induced by modulating immune therapy. To analyze immunological changes, immunophenotyping by flow cytometry is performed with blood from patients with malignant gliomas during their therapy concluding chemoradiation and chemotherapy alone. Count, class and activation status of immune cells are detected by flow cytometry. Together with additional analysis methods, information about immunological mediators like cytokines, chemokines and danger signals can be received. For these purposes serum and plasma are generated from blood samples and stored for prospective questions. The explorative determined results may also help to discover new, immunological based, prognostic or predictive tumor markers.
- Conditions
- Anaplastic Astrocytoma, Glioblastoma Multiforme
- Being tested
- Blood sample and life quality questionnaires
- Keywords
- Malignant glioma, Anaplastic astrocytoma, Glioblastoma multiforme, Immune, Immunophenotyping, Immune cells, activation state, Quality of live, translational research
- Medical subject headings
- Astrocytoma, Glioblastoma, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample and life quality questionnairesOther
Blood will be drawn at distinct time points during and after radio(chemo)therapy
| Study group | Role | What they receive |
|---|---|---|
| study patients | Blood sample and life quality questionnaires Receives: Other: Blood sample and life quality questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: patients will be followed for the duration of therapy and follow-up until recurrence, an expected average of 6 months
documentation of medication
Measured: 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
Measured: 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)
Measured: 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
Correlation with results of immunophenotyping, possibly definition of medically relevant markers
Measured: patients will be followed for the duration of therapy and follow-up until recurrence, an expected average of 6 months
overall survival
Measured: patients will be followed for the duration of therapy and follow-up until recurrence, an expected average of 6 months
progression free survival
Measured: patients will be followed for the duration of therapy and follow-up until recurrence, an expected average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2013 (estimated)
- Study startDec 2013
- Primary completion31 Dec 2021
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anaplastic AstrocytomaStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rainer Fietkau, Prof., Principal investigator, Department of Radiation Oncology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-NürnbergUdo S Gaipl, Prof., Principal investigator, Department of Radiation Oncology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02022384
- Sponsor's protocol ID
- IMMO-GLIO 01
- Status last verified
- Feb 2023
- First submitted
- 13 Dec 2013
- Last updated
- 16 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28690586
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunophenotyping From Blood From Patients With Glioblastoma and Anaplastic Astrocytoma Before and During Chemoradiation as Well as During Adjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT02022384
- Acronym / sponsor ID
- IMMO-GLIO 01
- Conditions
- Anaplastic Astrocytoma, Glioblastoma Multiforme
- Keywords
- Malignant glioma, Anaplastic astrocytoma, Glioblastoma multiforme, Immune, Immunophenotyping, Immune cells, activation state, Quality of live
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- Dec 2013 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 27 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients with malignant glioma generally have a bad prognosis. To improve patients' situation new therapy options as well as new possibilities to determine prognosis and prediction more precisely are needed. One approach is the targeted activation of the immune system to recognize and eliminate tumor cells. Due to cerebral tumors the brain is no immune privileged organ anymore, so that immune cells may pass the haemato-encephalic barrier to attack tumor cells. This study aims to offer valuable clues about how the immune system is influenced by standard therapies (radiotherapy and chemotherapy). Just with the background knowledge of immune mechanisms and influencing factors by tumor therapy, an effective anti-tumor response can systematically be induced by modulating immune therapy. To analyze immunological changes, immunophenotyping by flow cytometry is performed with blood from patients with malignant gliomas during their therapy concluding chemoradiation and chemotherapy alone. Count, class and activation status of immune cells are detected by flow cytometry. Together with additional analysis methods, information about immunological mediators like cytokines, chemokines and danger signals can be received. For these purposes serum and plasma are generated from blood samples and stored for prospective questions. The explorative determined results may also help to discover new, immunological based, prognostic or predictive tumor markers.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study patients | – | Other: Blood sample and life quality questionnairesBlood sample and life quality questionnaires |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with primary diagnosed glioblastoma multiforme or anaplastic astrocytoma
Key inclusion criteria (3 listed)
- patients with glioblastoma or anaplastic astrocytoma
- legal age
- planned chemoradiation and adjuvant chemotherapy (according to Stupp et. al.)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sample and life quality questionnairesBlood will be drawn at distinct time points during and after radio(chemo)therapy | Other | study patients |
Primary outcome
immunological state of patients comprising number, type and activation state of immune cells, cytokines and danger signals from peripheral blood
Time frame: patients will be followed for the duration of therapy and follow-up until recurrence, an expected average of 6 months
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.
7 secondary outcomes
Acquisition of toxicities according to Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0
Time frame: patients will be followed for the duration of therapy and follow-up until recurrence, an expected average of 6 months
documentation of medication
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: patients will be followed for the duration of therapy and follow-up until recurrence, an expected average of 6 months
overall survival
Time frame: patients will be followed for the duration of therapy and follow-up until recurrence, an expected average of 6 months
progression free survival
Time frame: patients will be followed for the duration of therapy and follow-up until recurrence, an expected average of 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- Derived from this study: PubMed 28690586Ruhle 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rainer Fietkau, Prof. principal investigator
Department of Radiation Oncology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg
Udo S Gaipl, Prof. principal investigator
Department of Radiation Oncology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anaplastic Astrocytoma and Glioblastoma Multiforme, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
immunological state of patients comprising number, type and activation state of immune cells, cytokines and danger signals from peripheral blood (time frame: patients will be followed for the duration of therapy and follow-up until recurrence, an expected average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02022384, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2023; AzTrials last refreshed its copy on 7 Nov 2026.