Non Interventional German Leptomeningeal Disease Register
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No intervention.
- Who it may be relevant to
- Registry conditions: Meningeal Neoplasms, Leptomeningeal Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Deutsches Meningeosis Neoplastica Register
Overview
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.
Interventions
- Other No intervention
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
Primary outcome measures
- Progression-free survival depending on the treatment modalities [Time frame: through study completion, an average of 1 year]
- Overall survival depending on the treatment modalities [Time frame: through study completion, an average of 1 year]
Secondary outcome measures (1)
- Frequency of adverse events during the course of the disease. [Time frame: through study completion, an average of 1 year]
Eligibility criteria
Inclusion criteria
- Patients with leptomeningeal disease
- Written consent of the patient or legal guardian.
- Capacity to give consent or legal guardianship
- Age ≥ 18 years
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Germany · 7 centers
- Universitätsklinikum Bonn Klinik und Poliklinik für Neurologie — Bonn
- Universitätsmedizin Mannheim Universitätsklinikum Mannheim GmbH Klinik für Neurologie — Mannheim
- Klinikum rechts der Isar | Technische Universität München; Klinik für Radioonkologie und S — München
- Überörtliche Gemeinschaftspraxis für Hämatologie und Onkologie — Münster
- Diakonie Klinikum GmbH • Jung-Stilling-KrankenhausAbteilung Neurochirurgie — Siegen
- University Hospital Tübingen, Neurooncology — Tübingen
- Universitätsklinikum Ulm; Klinik für Innere Medizin III — Ulm
Identifiers
NCT: NCT06146010 · Meningeosis Register