Non Interventional German Leptomeningeal Disease Register
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital Tuebingen
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with leptomeningeal disease
Written consent of the patient or legal guardian.
Capacity to give consent or legal guardianship
Age ≥ 18 years
Disqualifiers
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 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.
Trial design
Design model
Case-only
Time perspective
Other
Treatments tested in this trial
No intervention
Other 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.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: german leptomeningeal disease register1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
through study completion, an average of 1 year2
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.
Time frame
through study completion, an average of 1 yearSecondary 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.
Time frame
through study completion, an average of 1 yearSponsors and contacts
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Source ClinicalTrials.gov