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

June 21, 2017 updated by: Czech Lymphoma Study Group

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

20000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Marek Trneny, prof. MD
  • Phone Number: +420224962061
  • Email: trneny@cesnet.cz

Study Contact Backup

Study Locations

  • Czechia
      • Praha, Czechia, 128 08
        • Recruiting
        • Charles University General Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

new patients with non-Hodgkin´s lymphoma (NHL)

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • unsigned informed consent
  • age <18 y

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
On average once a year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
On average once a year
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)
On average once a year
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
On average once a year
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
On average once a year
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
On average once a year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Czech Lymphoma Study Group

Investigators

  • Principal Investigator: Marek Trneny, prof. MD, Charles University General Hospital, Prague, CZ

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 1999

Primary Completion (ANTICIPATED)

December 31, 2020

Study Completion (ANTICIPATED)

December 31, 2027

Study Registration Dates

First Submitted

June 14, 2017

First Submitted That Met QC Criteria

June 21, 2017

First Posted (ACTUAL)

June 26, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 26, 2017

Last Update Submitted That Met QC Criteria

June 21, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NiHiL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data are available only for reasearchers in CLSG.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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