Non Interventional German Leptomeningeal Disease Register

NCT06146010 | Recruiting

• 1 other identifier: Meningeosis Register
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Meningeal Neoplasms; Leptomeningeal Disease

Keywords

Meningeosis Neoplastica

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Frequency of adverse events during the course of the disease.

  through study completion, an average of 1 year

Study Arms (1)

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

Interventions

No intervention OTHER

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.

german leptomeningeal disease register

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients with leptomeningeal disease
• Written consent of the patient or legal guardian.
• Capacity to give consent or legal guardianship
• Age ≥ 18 years

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (7)

Universitätsklinikum Bonn Klinik und Poliklinik für Neurologie

Bonn, 53127, Germany

RECRUITING

Universitätsmedizin Mannheim Universitätsklinikum Mannheim GmbH Klinik für Neurologie

Mannheim, 68167, Germany

RECRUITING

Klinikum rechts der Isar | Technische Universität München; Klinik für Radioonkologie und Strahlentherapie

München, 81675, Germany

RECRUITING

Überörtliche Gemeinschaftspraxis für Hämatologie und Onkologie

Münster, 48153, Germany

NOT YET RECRUITING

Diakonie Klinikum GmbH • Jung-Stilling-KrankenhausAbteilung Neurochirurgie

Siegen, 57074, Germany

RECRUITING

University Hospital Tübingen, Neurooncology

Tübingen, 72076, Germany

RECRUITING

Universitätsklinikum Ulm; Klinik für Innere Medizin III

Ulm, 89081, Germany

RECRUITING

MeSH Terms

Conditions

Meningeal Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases

Central Study Contacts

Ghazaleh Tabatabai, Prof

CONTACT

+497071-29; Tabatabai.Office@med.uni-tuebingen.de

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2023
• First Posted: November 24, 2023
• Study Start: June 26, 2024
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: April 8, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (7)