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.

Non Interventional German Leptomeningeal Disease Register

Meningeal Neoplasms

Leptomeningeal Disease

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.

No intervention

Deutsches Meningeosis Neoplastica Register

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.

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.

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.

Non Interventional German Leptomeningeal Disease Register

About this trial

Study ID

Status

Type

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the participation requirements?