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NCT Number: NCT06043011

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

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.

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Key information

Conditions

Chronic Lymphocytic Leukemia (CLL) Blood Protein Disorders Cardiovascular Diseases Chronic Disease Diffuse Large B-Cell Lymphoma (DLBCL) Disease Attributes Follicular Lymphoma (FL) Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, B-Cell, Marginal Zone Lymphoma, Follicular Lymphoma, Large B-Cell, Diffuse Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Mantle Cell Lymphoma (MCL) Marginal Zone Lymphoma (MZL) Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases Waldenstrom Macroglobulinemia Waldenström's Macroglobulinemia (WM)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Praxis für Interdisziplinäre Hämatologie und Onkologie

Freiburg im Breisgau, Germany

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Routine care as per site standard.

Other

Physician's choice according to patient's needs.

Primary outcomes

  1. Course of treatment (treatment reality)

    Time frame: 5 years

    Documentation of anamnestic data and therapy sequences. Documentation of anamnestic data and therapy sequences

Secondary outcomes

  1. Best Response

    Time frame: 5 years

    Documentation of response rates per line of treatment.

  2. Progression-free survival

    Time frame: 5 years

    Documentation of progression-free survival per line of treatment.

  3. Overall survival

    Time frame: 5 years

    Documentation of overall survival time.

  4. Health-related quality of life (Patient-reported outcome)

    Time frame: 1 year

    EORTC QLQ-C30 core questionnaire

  5. Disease-specific quality of life (Patient-reported outcome, patients with CLL)

    Time frame: 1 year

    EORTC QLQ-CLL17

  6. Disease-specific quality of life (Patient-reported outcome, patients with LG-NHL)

    Time frame: 1 year

    EORTC QLQ-NHL-LG20

  7. Disease-specific quality of life (Patient-reported outcome, patients with HG-NHL)

    Time frame: 1 year

    EORTC QLQ-NHL-HG29

Study contacts

Contact information is provided by the study sponsor or research team.

Martina Jänicke, Dr.

CONTACT

[email protected]

+4976115242

Sponsors and collaborators

Lead sponsor

iOMEDICO AG

Industry

Registry information

Official study title

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

Acronym: RUBIN

Important dates

Study start
2023
Primary completion
2033
Study completion
2033
First posted
Sep 21, 2023
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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