Meningeoma001_2024_BO2NCT06709833
Meningioma and Embolism Thrombosis Risk & Investigation of Coagulation
An observational study of Meningeoma and Thrombembolism, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
Despite being generally benign tumors, meningiomas are associated with an increased risk for thrombembolic complications after surgical resection. The molecular mechanisms underlying this circumstance are still unknown. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Meningeoma, Thrombembolism, Surgical Resection
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 16 Dec 2024to 31 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with intracranial tumors 1. meningeoma 2. glioma (control)
Who may be able to join
- Patients undergoing resection for meningioma or
- Patients undergoing resection for glioma or
- Healthy controls
- written consent for study participation
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Hospital for Anaesthesiology and Intensive Care Medicine, Tuebingen
Tübingen, Baden-Wurttemberg, 72076
Alice Bernard, MD, 0049-7071-2968029, alice.bernard@med.uni-tuebingen.de
About this study
Despite being generally benign tumors, meningiomas are associated with an increased risk for thrombembolic complications after surgical resection. The molecular mechanisms underlying this circumstance are still unknown.
In this prospective observational trial, the investigators aim to evaluate the changes in coagulation and platelet function caused by tumor resection.
Blood samples are obtained by patients undergoing meningioma resection before and immediately after resection to detect said changes.
As a control cohort, blood samples are obtained from patients undergoing resection for glioma.
- Conditions
- Meningeoma, Thrombembolism, Surgical Resection
- Keywords
- meningeoma, thrombembolism, tissue-factor
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 |
|---|---|---|
| Meningioma resection | patients undergoing resection for meningioma | |
| Glioma resection | Patients undergoing glioma resection as a control cohort for meningioma patients | |
| Healthy controls | Healthy controls without tumor and surgical resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tissue factor
Concentration of tissue factor at pre-surgery and immediately after tumor resection (during close-up).
Measured: duration of surfical tumor resection (a few hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start16 Dec 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MeningeomaStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06709833
- Sponsor's protocol ID
- 001_2024_BO2
- Acronym
- 001_2024_BO2
- Status last verified
- Nov 2024
- First submitted
- 25 Nov 2024
- Last updated
- 6 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meningioma and Embolism Thrombosis Risk & Investigation of Coagulation
- ClinicalTrials.gov ID
- NCT06709833
- Acronym / sponsor ID
- 001_2024_BO2 / 001_2024_BO2
- Conditions
- Meningeoma, Thrombembolism, Surgical Resection
- Keywords
- meningeoma, thrombembolism, tissue-factor
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 16 Dec 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 29 Nov 2024 (actual)
- 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.
Despite being generally benign tumors, meningiomas are associated with an increased risk for thrombembolic complications after surgical resection. The molecular mechanisms underlying this circumstance are still unknown.
In this prospective observational trial, the investigators aim to evaluate the changes in coagulation and platelet function caused by tumor resection.
Blood samples are obtained by patients undergoing meningioma resection before and immediately after resection to detect said changes.
As a control cohort, blood samples are obtained from patients undergoing resection for glioma.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Meningioma resection | – | –patients undergoing resection for meningioma |
| Glioma resection | – | –Patients undergoing glioma resection as a control cohort for meningioma patients |
| Healthy controls | – | –Healthy controls without tumor and surgical resection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with intracranial tumors 1. meningeoma 2. glioma (control)
Key inclusion criteria (4 listed)
- Patients undergoing resection for meningioma or
- Patients undergoing resection for glioma or
- Healthy controls
- written consent for study participation
Key exclusion criteria (1 listed)
- -
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
Tissue factor
Time frame: duration of surfical tumor resection (a few hours)
Concentration of tissue factor at pre-surgery and immediately after tumor resection (during close-up).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2025.
- Individual participant dataSharing planned: No
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.
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 Meningeoma and Thrombembolism, run by University Hospital Tuebingen 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 4 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: looking for participants now, as of the sponsor's last update on 6 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Koeppen, MD (+4970712986935, michael.koeppen@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tissue factor (time frame: duration of surfical tumor resection (a few hours)). 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 6 Jan 2025.