JOURNAL ONKOLOGIE – STUDIE

Non Interventional German Leptomeningeal Disease Register

Studien-Informationen Einschlusskriterien Studien-Rationale Geprüfte Regime

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NCT-Nummer:
NCT06146010

Studienbeginn:
Januar 2024

Letztes Update:
24.11.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Meningeal Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
University Hospital Tuebingen

Collaborator:
-

Kontakt

Ghazaleh Tabatabai, Prof
Kontakt:
Phone: 0707129
Phone (ext.): 85018
E-Mail: Tabatabai.Office@med.uni-tuebingen.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

University Hospital Tübingen, Neurooncology
72076 Tübingen
(Baden-Württemberg)
Germany» Google-Maps

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Progression-free survival depending on the treatment modalities (Time Frame - through study completion, an average of 1 year):
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.

2. Overall survival depending on the treatment modalities (Time Frame - through study completion, an average of 1 year):
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.

Secondary outcome:

1. Frequency of adverse events during the course of the disease. (Time Frame - through study completion, an average of 1 year):
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.

Geprüfte Regime

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.

Quelle: ClinicalTrials.gov

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