Идёт набор NCT06043011

Registry Platform Hematologic Malignancies (RUBIN) - Extension of Tumor Registry Lymphatic Neoplasms

— Наблюдательное Chronic Lymphocytic Leukemia (CLL) Diffuse Large B-cell Lymphoma (DLBCL) Follicular Lymphoma (FL) Mantle Cell Lymphoma (MCL)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Routine care as per site standard..
Кому может быть актуально: Состояния в реестре: Chronic Lymphocytic Leukemia (CLL), Diffuse Large B-cell Lymphoma (DLBCL), Follicular Lymphoma (FL), Mantle Cell Lymphoma (MCL). Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Германия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Clinical Research Platform on Treatment, Quality of Life and Outcome of Patients With Hematologic Malignancies (RUBIN) - Extension of Tumor Registry Lymphatic Neoplasms

Обзор

The purpose of the project is to set up a national, prospective, longitudinal, multicenter registry platform to document uniform data on characteristics, molecular diagnostics, treatment and course of disease, to collect patient-reported outcomes and to establish a decentralized biobank for patients with hematological malignancies in Germany.

Подробное описание

RUBIN is a national, observational, prospective, longitudinal, multicenter registry platform with the purpose to record information on the antineoplastic treatment of hematological malignancies in Germany.

It will identify common therapeutic sequences and changes in the treatment of the disease, and will analyse the impact of novel treatments on the outcome of patients in routine care. Unmet needs and areas with the potential for improvement in routine care are to be identified.

At inclusion, data in patient characteristics, comorbidities, clinical characteristics and previous treatments, if applicable, are collected. During the course of observation data on all systemic treatments, radiotherapies, surgeries, and clinical outcome are documented.

Health-realted quality of life in patients with hematological malignancies will be evaluated for up to one year.

Вмешательства

Другое Routine care as per site standard.
Physician's choice according to patient's needs.

Первичные конечные точки

Course of treatment (treatment reality) [Срок оценки: 5 years]

Вторичные конечные точки (7)

Best Response [Срок оценки: 5 years]
Progression-free survival [Срок оценки: 5 years]
Overall survival [Срок оценки: 5 years]
Health-related quality of life (Patient-reported outcome) [Срок оценки: 1 year]
Disease-specific quality of life (Patient-reported outcome, patients with CLL) [Срок оценки: 1 year]
Disease-specific quality of life (Patient-reported outcome, patients with LG-NHL) [Срок оценки: 1 year]
Disease-specific quality of life (Patient-reported outcome, patients with HG-NHL) [Срок оценки: 1 year]

Критерии участия

Критерии включения

Age ≥ 18 years
Confirmed diagnosis of the respective NHL
If patient is alive: signed written informed consent

For patients participating in the PRO survey: IC prior to or at day of start of respective line of treatment.
For patients not participating in the PRO survey: IC latest eight weeks after start of respective line of treatment.