Clinical trial NCT03199066: Non-Hodgkin Lymphoma - Observational Epidemiological and Clinical Study (NiHiL)
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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non Hodgkin Lymphoma (NHL)
Keywords: survival
therapy
epidemiology
Lead sponsor: Czech Lymphoma Study Group
Sponsor class: OTHER
First posted: 2017-06-26
Enrollment: 20000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: new patients with non-Hodgkin´s lymphoma (NHL)

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* unsigned informed consent
* age \<18 y

Primary outcomes:
measure: lymphoma epidemiology in CZ
timeFrame: On average once a year
Secondary outcomes:
measure: clinical characteristics
timeFrame: On average once a year
measure: biological characteristics
timeFrame: On average once a year
measure: prognostic systems
timeFrame: On average once a year
measure: therapy used
timeFrame: On average once a year
measure: patients outcome
timeFrame: On average once a year
Other outcomes:
Locations:
city: Praha
country: Czechia
facility: Charles University General Hospital
Study officials:
affiliation: Charles University General Hospital, Prague, CZ
name: Marek Trneny, prof. MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.