Brazilian Prospective Hodgkin Lymphoma Registry

Hodgkin Lymphoma Clinical Trial

Official title:

Brazilian Prospective Hodgkin Lymphoma Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02589548
• Other study ID #: RBLH
• Status: Recruiting
• Start date: October 2009
• Est. completion date: December 2022

Study information

• Verified date: May 2022
• Source: Universidade Federal do Rio de Janeiro
• Contact: Nelson Spector, MD
• Phone: +552139382460
• Email: spector[@]ufrj.br
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study is a prospective registry of Hodgkin Lymphoma (HL) patients in Brazil. The purpose of the study is to gather clinical, epidemiologic and outcomes data on the treatment of HL, on the basis of records collected by key Brazilian institutions, through a centralized web-based registry of clinical data verified by central board of hematopathologists.

Description:

Hodgkin Lymphoma is considered one of the malignancies with highest cure rates. Its prognosis improved substantially along the last three decades, as a result of relevant cooperative studies carried out in American and European institutions. Around 70-80% of the patients are cured with the available chemotherapy regimens. However, data about HL in developing countries are scarce. It is well established that patients in underprivileged societies present with malignancies in more advanced stages. In studies of HL patients treated in Brazil during the 80's, most patients presented with advanced disease. The creation of registry of patients with HL will provide a more reliable picture of the disease in the country, its prevalence in different areas and socioeconomic groups, and treatment outcomes. It will also foster the establishment of a network among hospitals in all regions of the country, which may serve as a platform for further development of cooperative studies engaging the main Brazilian Institutions. The data collection allows comparison of data entered into the registry against predefined rules for range or consistency with other data fields in the registry. Also, quality assurance addresses data validation and data analysis. Standard descriptive analyses will be carried out. For a crude association analysis, categorical data will be analysed using the chi-square or Fisher's exact test (two-sided). Survival curves will be estimated using the Kaplan-Meier method and compare using the log-rank test. Univariate and multivariate Cox regression analyses will be conducted to verify the prognostic factors regarding Progression free survival and Overall survival, adjusted for relevant prognostic clinical variables and treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1400
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 100 Years

Eligibility

Inclusion Criteria:

• Previously untreated HL patients
• Clinical data including baseline information on disease localization and laboratory parameters at staging, features of treatment adopted and assurance of follow-up updating for at least 5 years are requested
• Written informed consent Exclusion Criteria: -

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin Lymphoma
• Lymphoma

Locations

Country	Name	City	State
Brazil	Universidade Federal Do Rio de Janeiro	Rio de Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Rio de Janeiro

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival	Overall Survival	5 years
Secondary	Event Free survival	Event free survival	5 years