Registry Platform Hematologic Malignancies (RUBIN) - Extension of Tumor Registry Lymphatic Neoplasms
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Routine care as per site standard..
- Who it may be relevant to
- Registry conditions: Chronic Lymphocytic Leukemia (CLL), Diffuse Large B-cell Lymphoma (DLBCL), Follicular Lymphoma (FL), Mantle Cell Lymphoma (MCL). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Clinical Research Platform on Treatment, Quality of Life and Outcome of Patients With Hematologic Malignancies (RUBIN) - Extension of Tumor Registry Lymphatic Neoplasms
Overview
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.
Detailed description
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.
Interventions
- Other Routine care as per site standard.
Physician's choice according to patient's needs.
Primary outcome measures
- Course of treatment (treatment reality) [Time frame: 5 years]
Secondary outcome measures (7)
- Best Response [Time frame: 5 years]
- Progression-free survival [Time frame: 5 years]
- Overall survival [Time frame: 5 years]
- Health-related quality of life (Patient-reported outcome) [Time frame: 1 year]
- Disease-specific quality of life (Patient-reported outcome, patients with CLL) [Time frame: 1 year]
- Disease-specific quality of life (Patient-reported outcome, patients with LG-NHL) [Time frame: 1 year]
- Disease-specific quality of life (Patient-reported outcome, patients with HG-NHL) [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- No systemic therapy for respective lymphoid malignancy.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- Praxis für Interdisziplinäre Hämatologie und Onkologie — Freiburg im Breisgau
Identifiers
NCT: NCT06043011 · iOM-080485