Non Hodgkin Lymphoma (NHL) Clinical Trial
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.
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.
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