NCT03199066

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20,000

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Jan 1999

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Jan 1999Dec 2027

Study Start

First participant enrolled

January 1, 1999

Completed
18.5 years until next milestone

First Submitted

Initial submission to the registry

June 14, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 26, 2017

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Expected
Last Updated

June 26, 2017

Status Verified

June 1, 2017

Enrollment Period

22 years

First QC Date

June 14, 2017

Last Update Submit

June 21, 2017

Conditions

Keywords

survivaltherapyepidemiology

Outcome Measures

Primary Outcomes (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

    On average once a year

Secondary Outcomes (5)

  • clinical characteristics

    On average once a year

  • biological characteristics

    On average once a year

  • prognostic systems

    On average once a year

  • therapy used

    On average once a year

  • patients outcome

    On average once a year

Study Arms (8)

All NHL subtypes

no interventions

DLBCL

only patients with diffuse large B-cell lymphoma

FL

only patients with follicular lymphoma

MCL

only patients with mantle cell lymphoma

SLL/CLL

only patients with small lymphocytic lymphoma / chronic lymphocytic leukemia

MZL

only patients with marginal zone lymphoma

other B-cell lymphomas

only patients with B-lymphomas not described above

T-cell lymphomas

only patients with all types of T-cell lymphoma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • unsigned informed consent
  • age \<18 y

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charles University General Hospital

Prague, 128 08, Czechia

RECRUITING

Related Publications (4)

  • 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.

  • 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.

  • 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.

  • 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.

Related Links

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Marek Trneny, prof. MD

    Charles University General Hospital, Prague, CZ

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marek Trneny, prof. MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2017

First Posted

June 26, 2017

Study Start

January 1, 1999

Primary Completion

December 31, 2020

Study Completion (Estimated)

December 31, 2027

Last Updated

June 26, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Individual participant data are available only for reasearchers in CLSG.

Locations