Meningeal NeoplasmsNCT06146010
Non Interventional German Leptomeningeal Disease Register
An observational study of Meningeal Neoplasms and Leptomeningeal Disease, run by University Hospital Tuebingen at 7 sites in Germany.
Trial summary
The planned multicenter register is intended to create a database in the form of a cancer register on the incidence and course of disease in Germany of leptomeningeal disease, the therapeutic measures administered in the real world and the complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meningeal Neoplasms, Leptomeningeal Disease
- How many people
- 50 participants
- Where
- 7 sitesGermany
- Study dates
- 26 Jun 2024to Dec 2029
- How long will I take part?
- 5 Years
- 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
- No healthy volunteers
- Adult, Older adult
Study population: The majority of patients observed are capable of giving consent. However, tumors of the central nervous system can lead to a psychosyndrome that restricts the patient's ability to give consent. Nevertheless, it is important to document and evaluate the course of the disease and the effects of the therapies administered, especially in these patients.
Who may be able to join
- Patients with leptomeningeal disease
- Written consent of the patient or legal guardian.
- Capacity to give consent or legal guardianship
- Age ≥ 18 years
Who cannot join
- Lack of informed consent from the patient
- Lack of capacity to consent on the part of the person concerned or lack of legal guardianship
- Age < 18 years
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Germany7 sites, 7 recruiting
- Recruiting
Universitätsklinikum Bonn Klinik und Poliklinik für Neurologie
Bonn, 53127
Ulrich Herrlinger, Prof. Dr., +49228 287 ext. 31241, Studienzentrum.neuroonkologie@ukbonn.de
Ulrich Herrlinger, Prof. Dr.
- Recruiting
Universitätsmedizin Mannheim Universitätsklinikum Mannheim GmbH Klinik für Neurologie
Mannheim, 68167
Lukas Bunse, Dr. Dr., +49621-383 ext. 5934, lukas.bunse@umm.de
Lukas Bunse, Dr. Dr.
- Recruiting
Klinikum rechts der Isar | Technische Universität München; Klinik für Radioonkologie und Strahlentherapie
München, 81675
Denise Bernhardt, Dr., +49 89 4140 ext. 4501, Denise.Bernhardt@mri.tum.de
Denise Bernhardt, Dr.
- Not yet recruiting
Überörtliche Gemeinschaftspraxis für Hämatologie und Onkologie
Münster, 48153
Rüdiger Liersch, PD Dr. med, +49 (0) 251 9764537, geho@onkologie-muenster.de
- Recruiting
Diakonie Klinikum GmbH • Jung-Stilling-KrankenhausAbteilung Neurochirurgie
Siegen, 57074
+49 271 333 ext. 42 20, Ajsela.Salkica@diakonie-sw.de
Ajsela Salkica, Dr.
- Recruiting
University Hospital Tübingen, Neurooncology
Tübingen, 72076
Ghazaleh Tabatabai, Prof. Dr., 497071/29-83269, ghazaleh.tabatabai@uni-tuebingen.de
- Recruiting
Universitätsklinikum Ulm; Klinik für Innere Medizin III
Ulm, 89081
Stefan Schoensteiner, Dr., +49731500 ext. 45747, studienzentrum.cccu@uniklinik-ulm.de
Stefan Schoensteiner, Dr.
About this study
Official title: Deutsches Meningeosis Neoplastica Register
The planned multicenter register is intended to create a database in the form of a cancer register on the incidence and course of disease in Germany of leptomeningeal disease, the therapeutic measures administered in the real world and the complications.
Read the detailed description
This register is multicenter project in Germany. All patients eligible for this register are informed in detail about the register verbally and in writing by the treating and documenting physicians. The written declaration of consent is attached to the patient information form. A patient will only be included in this register once the written declaration of consent has been provided by the patient or their legal guardian. Patient information and the obtaining of consent forms are carried out by the treating medical colleagues.
The register's data sources are the diagnostic findings made at the center and doctors' letters from routine clinical practice. The participating sites carry out the assessment of the participants' performance status so that the patients do not have to complete any study-related questionnaires. There is no intervention in this trial: neither changes to medication nor interventions on the patient themselves are carried out. Invasive measures are not carried out and there is no health risk associated with participation. Within the project, only the occurrence and severity of a neoplastic central nervous system infestation as well as the respective therapeutic measures and their results are documented.
Planned start of register: Quarter 1 2024 Expected end of register: Quarter 4 2029. Once the patient or their legal guardian has given written consent, a patient will be included in the German Meningeosis neoplastica Register. Due to the rapid course of the disease and potential rapid deterioration, the documentation of the course of the disease of the individual patients is to be carried out retrospectively from the clinical routine data recorded during the course of the study for the entire duration of the study or until the death of the participating patients after the written consent of the patients.
There is no minimum or maximum number of patients to be enrolled in this trial. Only descriptive analyses are planned for the data documented in the register.
In accordance with the Declaration of Helsinki/Tokyo/Venice/Hong Kong, all patients have the right to discontinue their participation in the register at any time and without giving reasons, without losing their right to further treatment or experiencing disadvantages of any other kind as a result. The data is pseudonymized and can be decrypted using the separately maintained key list. If a patient subsequently withdraws their consent to participate and requests that the data be deleted, this can be done after decryption using the key list. As this is a pure register study without study intervention, there are no plans to discontinue the entire study.
- Conditions
- Meningeal Neoplasms, Leptomeningeal Disease
- Being tested
- No intervention
- Keywords
- Meningeosis Neoplastica
- Medical subject headings
- Meningeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Once the patient or their legal guardian has given their written consent, a patient is included in the leptomeningeal disease register. Due to the rapid course of the disease and potential rapid deterioration, the documentation of the course of the disease of the individual patients is to be carried out retrospectively from the data recorded during the course of the clinical routine for the entire duration of the study or until the death of the participating patients after the written consent of the patients. The registry's data sources are the diagnostic findings made at the center and doctors' letters from routine clinical practice. The participating centers carry out the assessment of the participants' performance status so that the patients do not have to complete any study-related questionnaires.
| Study group | Role | What they receive |
|---|---|---|
| german leptomeningeal disease register | The aim of the leptomeningeal disease register is to establish an internet-based cancer register in which patients with leptomeningeal disease are recorded at the time of diagnosis and after appropriate information and consent to data collection. Due to the rapid progression of the disease and potential rapid deterioration, inclusion must take place at the time of diagnosis. The course of the disease in individual patients is then documented retrospectively on the basis of routine clinical care data for the entire duration of the study or until the death of the participating patients. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival depending on the treatment modalities
Only descriptive analyses are planned for the data documented in the register. Absolute and percentage frequencies including two-sided 95% confidence intervals are determined for the frequency of use of certain treatment regimens.
Measured: through study completion, an average of 1 year
Overall survival depending on the treatment modalities
Only descriptive analyses are planned for the data documented in the register. Absolute and percentage frequencies including two-sided 95% confidence intervals are determined for the frequency of use of certain treatment regimens.
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Frequency of adverse events during the course of the disease.
With regard to the effect of the documented therapies, absolute and percentage frequencies for treatment response including two-sided 95% confidence intervals are determined. For censored data (OS, PFS), survival probabilities including two-sided 95% confidence intervals are determined using the Kaplan Meier method. Events are collected retrospectively and presented using line listings and frequency tables.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study start26 Jun 2024
- Primary completionJan 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meningeal NeoplasmsStudies 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
- Case only
- Time perspective
- Other
- Enrolment
- 50 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06146010
- Sponsor's protocol ID
- Meningeosis Register
- Status last verified
- Mar 2026
- First submitted
- 6 Nov 2023
- Last updated
- 8 Apr 2026
- 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 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deutsches Meningeosis Neoplastica Register
- ClinicalTrials.gov ID
- NCT06146010
- Acronym / sponsor ID
- Meningeosis Register
- Conditions
- Meningeal Neoplasms, Leptomeningeal Disease
- Keywords
- Meningeosis Neoplastica
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 26 Jun 2024 (actual)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 24 Nov 2023 (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.
The planned multicenter register is intended to create a database in the form of a cancer register on the incidence and course of disease in Germany of leptomeningeal disease, the therapeutic measures administered in the real world and the complications.
Detailed description
This register is multicenter project in Germany. All patients eligible for this register are informed in detail about the register verbally and in writing by the treating and documenting physicians. The written declaration of consent is attached to the patient information form. A patient will only be included in this register once the written declaration of consent has been provided by the patient or their legal guardian. Patient information and the obtaining of consent forms are carried out by the treating medical colleagues.
The register's data sources are the diagnostic findings made at the center and doctors' letters from routine clinical practice. The participating sites carry out the assessment of the participants' performance status so that the patients do not have to complete any study-related questionnaires. There is no intervention in this trial: neither changes to medication nor interventions on the patient themselves are carried out. Invasive measures are not carried out and there is no health risk associated with participation. Within the project, only the occurrence and severity of a neoplastic central nervous system infestation as well as the respective therapeutic measures and their results are documented.
Planned start of register: Quarter 1 2024 Expected end of register: Quarter 4 2029. Once the patient or their legal guardian has given written consent, a patient will be included in the German Meningeosis neoplastica Register. Due to the rapid course of the disease and potential rapid deterioration, the documentation of the course of the disease of the individual patients is to be carried out retrospectively from the clinical routine data recorded during the course of the study for the entire duration of the study or until the death of the participating patients after the written consent of the patients.
There is no minimum or maximum number of patients to be enrolled in this trial. Only descriptive analyses are planned for the data documented in the register.
In accordance with the Declaration of Helsinki/Tokyo/Venice/Hong Kong, all patients have the right to discontinue their participation in the register at any time and without giving reasons, without losing their right to further treatment or experiencing disadvantages of any other kind as a result. The data is pseudonymized and can be decrypted using the separately maintained key list. If a patient subsequently withdraws their consent to participate and requests that the data be deleted, this can be done after decryption using the key list. As this is a pure register study without study intervention, there are no plans to discontinue the entire study.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| german leptomeningeal disease register | – | Other: No interventionThe aim of the leptomeningeal disease register is to establish an internet-based cancer register in which patients with leptomeningeal disease are recorded at the time of diagnosis and after appropriate information and consent to data collection. Due to the rapid progression of the disease and potential rapid deterioration, inclusion must take place at the time of diagnosis. The course of the disease in individual patients is then documented retrospectively on the basis of routine clinical care data for the entire duration of the study or until the death of the participating patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The majority of patients observed are capable of giving consent. However, tumors of the central nervous system can lead to a psychosyndrome that restricts the patient's ability to give consent. Nevertheless, it is important to document and evaluate the course of the disease and the effects of the therapies administered, especially in these patients.
Key inclusion criteria (4 listed)
- Patients with leptomeningeal disease
- Written consent of the patient or legal guardian.
- Capacity to give consent or legal guardianship
- Age ≥ 18 years
Key exclusion criteria (3 listed)
- Lack of informed consent from the patient
- Lack of capacity to consent on the part of the person concerned or lack of legal guardianship
- Age < 18 years
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 |
|---|---|---|
| No interventionOnce the patient or their legal guardian has given their written consent, a patient is included in the leptomeningeal disease register. Due to the rapid course of the disease and potential rapid deterioration, the documentation of the course of the disease of the individual patients is to be carried out retrospectively from the data recorded during the course of the clinical routine for the entire duration of the study or until the death of the participating patients after the written consent of the patients. The registry's data sources are the diagnostic findings made at the center and doctors' letters from routine clinical practice. The participating centers carry out the assessment of the participants' performance status so that the patients do not have to complete any study-related questionnaires. | Other | german leptomeningeal disease register |
Primary outcome
Progression-free survival depending on the treatment modalities
Time frame: through study completion, an average of 1 year
Only descriptive analyses are planned for the data documented in the register. Absolute and percentage frequencies including two-sided 95% confidence intervals are determined for the frequency of use of certain treatment regimens.
Overall survival depending on the treatment modalities
Time frame: through study completion, an average of 1 year
Only descriptive analyses are planned for the data documented in the register. Absolute and percentage frequencies including two-sided 95% confidence intervals are determined for the frequency of use of certain treatment regimens.
1 secondary outcome
Frequency of adverse events during the course of the disease.
Time frame: through study completion, an average of 1 year
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 8 Apr 2026.
- Individual participant dataSharing planned: No
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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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Meningeal Neoplasms and Leptomeningeal Disease, run by University Hospital Tuebingen at 7 sites 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 3 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 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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 Ghazaleh Tabatabai, Prof (+497071-29 ext. 85018, Tabatabai.Office@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival depending on the treatment modalities (time frame: through study completion, an average of 1 year). The study lists 2 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 8 Apr 2026.