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Non Hodgkin Lymphoma (NHL)NCT03199066

Non-Hodgkin Lymphoma - Observational Epidemiological and Clinical Study (NiHiL)

An observational study of Non Hodgkin Lymphoma (NHL), run by Czech Lymphoma Study Group at 1 site in Czechia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The Czech National Lymphoma Registry (NiHiL) was founded to monitor epidemiologic data and improve the diagnostic evaluation and quality of treatment of patients with non-Hodgkin´s lymphoma (NHL). The patients are registered into the registry in anonymized form. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non Hodgkin Lymphoma (NHL)
How many people
20,000 participants
Where
1 siteCzechia
Study dates
1 Jan 1999to 31 Dec 2027
How long will I take part?
10 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: new patients with non-Hodgkin´s lymphoma (NHL)

Who may be able to join

  • lymphoma diagnosis
  • treated in the Czech Republic
  • signed informed consent

Who cannot join

  • unsigned informed consent
  • age <18 y

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Marek Trneny, prof. MD contact

+420224962061

trneny@cesnet.cz

David Belada, MD contact

+420495 832 866

david.belada@seznam.cz

Czechia1 site, 1 recruiting

  • Charles University General Hospital

    Prague, 128 08

    Marek Trneny, prof.MD, +420224962061, trneny@cesnet.cz

    David Belada, MD, +420495 832 866, david.belada@seznam.cz

    Recruiting

Other trials in Czechia

About this study

Official title: The Incidence, Epidemiology, Clinical Characteristic, Prognostic Factors, Therapy and Outcome of Non-Hodgkin Lymphoma Patients in the Czech Republic. NiHiL- Longitudinal Observational Study of Czech Lymphoma Study Group (CLSG)

The Czech National Lymphoma Registry (NiHiL) was founded to monitor epidemiologic data and improve the diagnostic evaluation and quality of treatment of patients with non-Hodgkin´s lymphoma (NHL).

The patients are registered into the registry in anonymized form. For each patient are available: registration form, diagnostic form, treatment form, follow- up form, and other malignancy form.

Data quality in the NiHiL has been checked by audits. The data is analyzed according to NHL subtypes with endpoints: lymphoma distribution, epidemiological data, prognostic characteristic, treatment characteristics, response rate, relapse rate, mortality, PFS, OS, DFS, Lymphoma specific survival, longterm toxicity.

Read the detailed description

The Czech National Lymphoma Registry (NiHiL) was established in 1999 in order to monitor epidemiologic data and to improve the diagnostic evaluation and quality of treatment of patients with non-Hodgkin´s lymphoma (NHL). The database NiHiL includes majority of patients with NHL in the Czech Republic, treated in one of seven University Hospitals and other smaller centres. This represents approx. 75% of all lymphoma patients in the Czech Republic. Since 1999 until the end of year 2016 there were registered 14000 pts.

The patients are registered into the registry in anonymized form at the time of diagnosis after signing informed consent and data are updated/collected at the end of first line treatment, at each relapse including therapy for relapse and then annual follow-up and at the time of death. The registration is submitted electronically via secure internet system. For each patient are available following forms: registration form, diagnostic form, treatment form, follow- up form, and other malignancy form. The content of diagnostic form consists of diagnosis according WHO classification including the copy of original histology description, date of diagnosis, clinical stage, B symptoms, nodal and extranodal involvement, laboratory findings and prognostic systems (IPI, aaIPI, MIPI, FLIPII and others). The prognostic system is calculated automatically. The diagnostic form is the same for the first diagnosis and for the relapses. The treatment form consists of detailed information on the treatment: chemotherapy regimens, therapy with monoclonal antibodies, radiotherapy, autologous or allogeneic transplant. Response assessment has been adjusted to the different version of Chesson criteria for malignant lymphoma. It is expected that comorbidity score and toxicities evaluation will be added into the therapeutic form too.

The follow-up form is requested to be updated annually, besides that in case of relapse or death. This form includes information about clinical status, date of relapse or death.

The exports made from NiHiL content all data from registry and survival data (overall survival, progression survival and disease free survival).

Data quality in the NiHiL has been checked by audits recently, which have been carried out in each centre twice a year.

The data is analyzed according to NHL subtypes with endpoints: lymphoma distribution, epidemiological data, prognostic characteristic, treatment characteristics, response rate, relapse rate, mortality, PFS, OS, DFS, Lymphoma specific survival, longterm toxicity.

The registry has been repeatedly supported by the grants of Ministry of Health. A substantial number of papers originated from the NiHiL have been published in last 15 years in both Czech and international journals. The main aim of the registry is to collect data for malignant lymphoma for better understanding of epidemiological and clinical data about this disease.

Keywords
survival, therapy, epidemiology
Medical subject headings
Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03199066
Study groupRoleWhat they receive
All NHL subtypesno interventions
DLBCLonly patients with diffuse large B-cell lymphoma
FLonly patients with follicular lymphoma
MCLonly patients with mantle cell lymphoma
SLL/CLLonly patients with small lymphocytic lymphoma / chronic lymphocytic leukemia
MZLonly patients with marginal zone lymphoma
other B-cell lymphomasonly patients with B-lymphomas not described above
T-cell lymphomasonly patients with all types of T-cell lymphoma

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. lymphoma epidemiology in CZ

    occurrence and study of factors influencing the formation of non-hodgkin´s lymphoma from data filled into registry forms by physicians and datamangers

    Measured: On average once a year

Secondary outcomes (5)

  1. clinical characteristics

    patients clinical characteristics from data filled into registry forms by physicians and datamangers (values of lactate dehydrogenase, clinical stage, performance status, age ≥ 60 years and number of extranodal localizations will be combined to report IPI /International prognostic index/; other prognostic risk factors will be calculated similarly)

    Measured: On average once a year

  2. biological characteristics

    patients biological characteristics from data filled into registry forms by physicians and datamangers (immunohistochemical differences of non-hodgkin´s lymphomas, e.g. GC-like or non GC-like phenotype of DLBCL)

    Measured: On average once a year

  3. prognostic systems

    evaluation of prognostic factors based on subtypes of lymphoma from data filled into registry forms by physicians and datamangers

    Measured: On average once a year

  4. therapy used

    type of therapy - induction or following therapy - for all patients from data filled into registry forms by physicians and datamangers

    Measured: On average once a year

  5. patients outcome

    Overall response is measured according to Revised Response Criteria For Malignant Lymphoma (Cheson BD et al, JCO 2007; the main examinations PET/CT and bone marrow biopsy) for all patients, who can be evaluated

    Measured: On average once a year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2017
  2. Study start1 Jan 1999
  3. Primary completion31 Dec 2020 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
20,000 participants (estimated)
Target duration
10 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT03199066
Sponsor's protocol ID
NiHiL
Status last verified
Jun 2017
First submitted
14 Jun 2017
Last updated
26 Jun 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data are available only for reasearchers in CLSG.

Publications

  • Vodicka P, Janikova A, Belada D, Hanackova V, Mocikova H, Duras J, Steinerova K, Benesova K, Konirova E, Prochazka T, Polgarova K, Masar M, Dlouha J, Blahovcova P, Trneny M. Long-Term Real-World Outcomes of Primary CNS Lymphoma Patients Treated With MATRix Regimen Are Similar to IELSG32 Trial Results. Hematol Oncol. 2025 Nov;43(6):e70142. doi: 10.1002/hon.70142.

    PubMed 41108618

  • Mocikova H, Pytlik R, Benesova K, Janikova A, Duras J, Sykorova A, Steinerova K, Prochazka V, Campr V, Belada D, Trneny M. Peripheral T-Cell Lymphomas Involving the Central Nervous System: A Report From the Czech Lymphoma Study Group Registry. Front Oncol. 2022 May 12;12:874462. doi: 10.3389/fonc.2022.874462. eCollection 2022.

    PubMed 35646641

  • Vodicka P, Benesova K, Janikova A, Prochazka V, Belada D, Mocikova H, Steinerova K, Duras J, Karban J, Hanackova V, Sykorova A, Obr A, Trneny M. Polatuzumab vedotin plus bendamustine and rituximab in patients with relapsed/refractory diffuse large B-cell lymphoma in the real world. Eur J Haematol. 2022 Aug;109(2):162-165. doi: 10.1111/ejh.13784. Epub 2022 May 11.

    PubMed 35502609

  • Lobello C, Tichy B, Bystry V, Radova L, Filip D, Mraz M, Montes-Mojarro IA, Prokoph N, Larose H, Liang HC, Sharma GG, Mologni L, Belada D, Kamaradova K, Fend F, Gambacorti-Passerini C, Merkel O, Turner SD, Janikova A, Pospisilova S. STAT3 and TP53 mutations associate with poor prognosis in anaplastic large cell lymphoma. Leukemia. 2021 May;35(5):1500-1505. doi: 10.1038/s41375-020-01093-1. Epub 2020 Nov 27. No abstract available.

    PubMed 33247178

Questions about this trial

What is this clinical trial studying?

An observational study of Non Hodgkin Lymphoma (NHL), run by Czech Lymphoma Study Group at 1 site in Czechia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Marek Trneny, prof. MD (+420224962061, trneny@cesnet.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

lymphoma epidemiology in CZ (time frame: On average once a year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03199066, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2017.

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