ClinicalTrials.gov record NCT06043011
Registry Platform Hematologic Malignancies (RUBIN) - Extension of Tumor Registry Lymphatic Neoplasms
Clinical Research Platform on Treatment, Quality of Life and Outcome of Patients With Hematologic Malignancies (RUBIN) - Extension of Tumor Registry Lymphatic Neoplasms
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This is a prospective, longitudinal registry that collects real-world data on treatment and outcomes for people with several lymphoid blood cancers who receive systemic therapy. It records diagnosis details, molecular diagnostics, treatment sequences, clinical outcomes, and patient-reported quality of life, and establishes a decentralized biobank. Participants are followed for up to five years, with quality-of-life surveys for up to one year.
What it is studying. The study aims to document real-world treatment patterns and sequences, record response and survival outcomes, collect health-related and disease-specific quality-of-life data, and build a decentralized biobank to support future research.
What the researchers hope to learn. Describe real-world treatment patterns and common therapeutic sequences; analyze the impact of novel treatments on outcomes in routine care; identify unmet needs and areas for improvement; document response rates, progression-free survival, overall survival, and health-related and disease-specific quality-of-life.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Other
- Routine care as per site standard.
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
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.
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Detailed description from the registry
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.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Allow study staff to collect medical and treatment information from your records at enrollment and during follow‑up (documentation of systemic treatments, radiotherapy, surgeries, treatment sequences, and clinical outcomes) for up to 5 years. Complete health‑related and disease‑specific questionnaires (patient‑reported outcomes) for up to 1 year (for example EORTC QLQ‑C30 and lymphoma‑specific modules). You may be asked to provide biological samples for a decentralized biobank. Treatment decisions remain with your treating physician and no study treatment is assigned by the registry.
How the study is structured. A prospective observational cohort (registry). Participants receive routine care chosen by their physicians; the study does not assign treatments. At enrollment and during follow-up, the study collects medical data on diagnosis, molecular tests, treatments (systemic therapies, radiotherapy, surgeries), clinical outcomes, and patient-reported quality-of-life questionnaires. Follow-up is planned for up to five years, with quality-of-life surveys for up to one year and storage of samples in a decentralized biobank.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
- The listed sites are in Germany. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
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Important dates
- Study start
- Sep 27, 2023
- Primary completion
- December 2033 (estimated)
- Study completion
- December 2033 (estimated)
- Target enrollment
- 2950 participants (estimated)
- Last updated on registry
- Jul 13, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- iOMEDICO AG
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Martina Jänicke, Dr. 📞 +4976115242 ext. 0 ✉ rubin@iomedico.com
Participating sites (1)
- Praxis für Interdisziplinäre Hämatologie und OnkologieRecruiting
Freiburg im Breisgau · Germany
Terms used on this page · explanations by MedicalUpdates.ai
- registry
- An organised collection of information about people with a particular condition, gathered over time for research. Joining a registry usually means sharing medical information, not receiving a treatment.
- biobank
- A collection of biological samples, such as blood or tissue, stored with medical information so that researchers can study them later.
- written informed consent
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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