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

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03199066
• Other study ID #: NiHiL
• Status: Recruiting
• Phase: N/A
• First received: June 14, 2017
• Last updated: June 21, 2017
• Start date: January 1, 1999
• Est. completion date: December 31, 2027

Study information

• Verified date: June 2017
• Source: Czech Lymphoma Study Group
• Contact: Marek Trneny, prof. MD
• Phone: +420224962061
• Email: trneny[@]cesnet.cz
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20000
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• lymphoma diagnosis

• treated in the Czech Republic

• signed informed consent

Exclusion Criteria:

• unsigned informed consent

• age <18 y

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Non Hodgkin Lymphoma (NHL)

Locations

Country	Name	City	State
Czechia	Charles University General Hospital	Praha

Sponsors (1)

Lead Sponsor	Collaborator
Czech Lymphoma Study Group

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)	On average once a year
Secondary	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)	On average once a year
Secondary	prognostic systems	evaluation of prognostic factors based on subtypes of lymphoma from data filled into registry forms by physicians and datamangers	On average once a year
Secondary	therapy used	type of therapy - induction or following therapy - for all patients from data filled into registry forms by physicians and datamangers	On average once a year
Secondary	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	On average once a year

External Links

•   Official Site of the Czech Lymphoma Study Group