Non Interventional German Leptomeningeal Disease Register

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.

Study Overview

• Status: Recruiting
• Conditions: Meningeal Neoplasms; Leptomeningeal Disease
• Intervention / Treatment: Other: No intervention

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 Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Ghazaleh Tabatabai, Prof; Phone Number: 85018 +497071-29; Email: Tabatabai.Office@med.uni-tuebingen.de

Study Locations

• Germany
  • Bonn, Germany, 53127
    • Recruiting
    • Universitätsklinikum Bonn Klinik und Poliklinik für Neurologie
    • Contact: Ulrich Herrlinger, Prof. Dr.; Phone Number: 31241 +49228 287; Email: Studienzentrum.neuroonkologie@ukbonn.de
    • Principal Investigator: Ulrich Herrlinger, Prof. Dr.
  • Mannheim, Germany, 68167
    • Recruiting
    • Universitätsmedizin Mannheim Universitätsklinikum Mannheim GmbH Klinik für Neurologie
    • Contact: Lukas Bunse, Dr. Dr.; Phone Number: 5934 +49621-383; Email: lukas.bunse@umm.de
    • Principal Investigator: Lukas Bunse, Dr. Dr.
  • München, Germany, 81675
    • Recruiting
    • Klinikum rechts der Isar | Technische Universität München; Klinik für Radioonkologie und Strahlentherapie
    • Contact: Denise Bernhardt, Dr.; Phone Number: 4501 +49 89 4140; Email: Denise.Bernhardt@mri.tum.de
    • Principal Investigator: Denise Bernhardt, Dr.
  • Münster, Germany, 48153
    • Not yet recruiting
    • Überörtliche Gemeinschaftspraxis für Hämatologie und Onkologie
    • Contact: Rüdiger Liersch, PD Dr. med; Phone Number: +49 (0) 251 9764537; Email: geho@onkologie-muenster.de
  • Siegen, Germany, 57074
    • Recruiting
    • Diakonie Klinikum GmbH • Jung-Stilling-KrankenhausAbteilung Neurochirurgie
    • Contact: Phone Number: 42 20 +49 271 333; Email: Ajsela.Salkica@diakonie-sw.de
    • Principal Investigator: Ajsela Salkica, Dr.
  • Tübingen, Germany, 72076
    • Recruiting
    • University Hospital Tübingen, Neurooncology
    • Contact: Ghazaleh Tabatabai, Prof. Dr.; Phone Number: 497071/29-83269; Email: ghazaleh.tabatabai@uni-tuebingen.de
  • Ulm, Germany, 89081
    • Recruiting
    • Universitätsklinikum Ulm; Klinik für Innere Medizin III
    • Contact: Stefan Schoensteiner, Dr.; Phone Number: 45747 +49731500; Email: studienzentrum.cccu@uniklinik-ulm.de
    • Principal Investigator: Stefan Schoensteiner, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: University Hospital Tuebingen

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2024
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: November 6, 2023
• First Submitted That Met QC Criteria: November 16, 2023
• First Posted (Actual): November 24, 2023

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Meningeosis Neoplastica
• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms by Site; Neoplasms; Nervous System Neoplasms; Central Nervous System Neoplasms; Meningeal Neoplasms
• Other Study ID Numbers: Meningeosis Register

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No