GlioblastomaGPASNCT02887417
Glioblastoma Platelet Activation Study
An observational study of Glioblastoma and Circulating Platelet-monocyte Conjugates, run by University Medicine Greifswald at 1 site in Germany.
Trial summary
Glioblastoma face an increased risk of venous or arterial thromboembolism. Furthermore, the most frequent immune cells in glioblastoma are tumor associated macrophages, which find theirself in an anti-inflammatory (M2) phenotype. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Glioblastoma, Circulating Platelet-monocyte Conjugates
- How many people
- 21 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2016to Dec 2016
- 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: consecutive patients with suspicious for glioblastoma
Who may be able to join
- MR-morphological suspicion for glioblastoma
- informed consent
Who cannot join
- no informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Glioblastoma face an increased risk of venous or arterial thromboembolism. Furthermore, the most frequent immune cells in glioblastoma are tumor associated macrophages, which find theirself in an anti-inflammatory (M2) phenotype.
Increased conjugates between circulating platelets and monocytes reflect an pro-inflammatory status.
Read the detailed description
Glioblastoma face an increased risk of venous or arterial thromboembolism. Furthermore, the most frequent immune cells in glioblastoma are tumor associated macrophages, which find theirself in an anti-inflammatory (M2) phenotype.
Increased conjugates between circulating platelets and monocytes reflect an pro-inflammatory status.
- Keywords
- platelet activation
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients | glioblastoma patients | |
| controls | healthy controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean P-selectine expression in all platelets
Measured: 01/ 2016 - 10/ 2016
Mean CD63 expression in all platelets
Measured: 01/ 2016 - 10/ 2016
Mean CD40 Expression in all platelets
Measured: 01/ 2016 - 10/ 2016
Mean platelet-monocyte-conjugate formation in the monocyte population
Measured: 01/ 2016 - 10/ 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2016 (estimated)
- Study startJan 2016
- Primary completionOct 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sascha Marx, University Medicine Greifswald
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02887417
- Sponsor's protocol ID
- Glioma-HGW
- Acronym
- GPAS
- Status last verified
- Jul 2017
- First submitted
- 18 Aug 2016
- Last updated
- 1 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glioblastoma Platelet Activation Study
- ClinicalTrials.gov ID
- NCT02887417
- Acronym / sponsor ID
- GPAS / Glioma-HGW
- Keywords
- platelet activation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 2 Sep 2016 (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.
Glioblastoma face an increased risk of venous or arterial thromboembolism. Furthermore, the most frequent immune cells in glioblastoma are tumor associated macrophages, which find theirself in an anti-inflammatory (M2) phenotype.
Increased conjugates between circulating platelets and monocytes reflect an pro-inflammatory status.
Detailed description
Glioblastoma face an increased risk of venous or arterial thromboembolism. Furthermore, the most frequent immune cells in glioblastoma are tumor associated macrophages, which find theirself in an anti-inflammatory (M2) phenotype.
Increased conjugates between circulating platelets and monocytes reflect an pro-inflammatory status.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients | – | –glioblastoma patients |
| controls | – | –healthy controls |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- consecutive patients with suspicious for glioblastoma
Key inclusion criteria (2 listed)
- MR-morphological suspicion for glioblastoma
- informed consent
Key exclusion criteria (1 listed)
- no informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mean P-selectine expression in all platelets
Time frame: 01/ 2016 - 10/ 2016
Mean CD63 expression in all platelets
Time frame: 01/ 2016 - 10/ 2016
Mean CD40 Expression in all platelets
Time frame: 01/ 2016 - 10/ 2016
Mean platelet-monocyte-conjugate formation in the monocyte population
Time frame: 01/ 2016 - 10/ 2016
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 1 Aug 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Glioblastoma and Circulating Platelet-monocyte Conjugates, run by University Medicine Greifswald 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 2 inclusion and 1 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 1 Aug 2017. 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?
Mean P-selectine expression in all platelets (time frame: 01/ 2016 - 10/ 2016). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Aug 2017.