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

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ClinicalTrials.gov Identifier: NCT03199066
Recruitment Status : Recruiting
First Posted : June 26, 2017
Last Update Posted : June 26, 2017
Sponsor:
Information provided by (Responsible Party):
Czech Lymphoma Study Group

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.


Condition or disease
Non Hodgkin Lymphoma (NHL)

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 20000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
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)
Actual Study Start Date : January 1, 1999
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Group/Cohort
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



Primary Outcome Measures :
  1. lymphoma epidemiology in CZ [ Time Frame: On average once a year ]
    occurrence and study of factors influencing the formation of non-hodgkin´s lymphoma from data filled into registry forms by physicians and datamangers


Secondary Outcome Measures :
  1. clinical characteristics [ Time Frame: On average once a year ]
    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)

  2. biological characteristics [ Time Frame: On average once a year ]
    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)

  3. prognostic systems [ Time Frame: On average once a year ]
    evaluation of prognostic factors based on subtypes of lymphoma from data filled into registry forms by physicians and datamangers

  4. therapy used [ Time Frame: On average once a year ]
    type of therapy - induction or following therapy - for all patients from data filled into registry forms by physicians and datamangers

  5. patients outcome [ Time Frame: On average once a year ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
new patients with non-Hodgkin´s lymphoma (NHL)
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • unsigned informed consent
  • age <18 y

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03199066


Contacts
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Contact: Marek Trneny, prof. MD +420224962061 trneny@cesnet.cz
Contact: David Belada, MD +420495 832 866 david.belada@seznam.cz

Locations
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Czechia
Charles University General Hospital Recruiting
Praha, Czechia, 128 08
Contact: Marek Trneny, prof.MD    +420224962061    trneny@cesnet.cz   
Contact: David Belada, MD    +420495 832 866    david.belada@seznam.cz   
Sponsors and Collaborators
Czech Lymphoma Study Group
Investigators
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Principal Investigator: Marek Trneny, prof. MD Charles University General Hospital, Prague, CZ

Additional Information:
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Responsible Party: Czech Lymphoma Study Group
ClinicalTrials.gov Identifier: NCT03199066     History of Changes
Other Study ID Numbers: NiHiL
First Posted: June 26, 2017    Key Record Dates
Last Update Posted: June 26, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data are available only for reasearchers in CLSG.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Czech Lymphoma Study Group:
survival
therapy
epidemiology
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases