Non-Hodgkin Lymphoma - Observational Epidemiological and Clinical Study (NiHiL)
ConditionNon Hodgkin Lymphoma (NHL)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCzech Lymphoma Study Group
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
lymphoma diagnosis
treated in the Czech Republic
signed informed consent
Disqualifiers
unsigned informed consent
age <18 y
Trial population
new patients with non-Hodgkin´s lymphoma (NHL)
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
20,000 Participants
are grouped into 8 trial groups8
Trial groupsSee each trial group below.
Group A: All NHL subtypes
Group B: DLBCL
Group C: FL
Group D: MCL
Group E: SLL/CLL
Group F: MZL
Group G: other B-cell lymphomas
Group H: T-cell lymphomas
Trial outcomes
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
Time frame
On average once a yearSecondary outcomes
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)
Time frame
On average once a year2
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)
Time frame
On average once a year3
prognostic systems
evaluation of prognostic factors based on subtypes of lymphoma from data filled into registry forms by physicians and datamangers
Time frame
On average once a year4
therapy used
type of therapy - induction or following therapy - for all patients from data filled into registry forms by physicians and datamangers
Time frame
On average once a yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov