Brazilian Prospective Hodgkin Lymphoma Registry
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|ClinicalTrials.gov Identifier: NCT02589548|
Recruitment Status : Recruiting
First Posted : October 28, 2015
Last Update Posted : January 9, 2019
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.
|Condition or disease|
|Hodgkin Lymphoma Hodgkin Disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||1400 participants|
|Official Title:||Brazilian Prospective Hodgkin Lymphoma Registry|
|Study Start Date :||October 2009|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
- Overall Survival [ Time Frame: 5 years ]Overall Survival
- Event Free survival [ Time Frame: 5 years ]Event free survival
Biospecimen Retention: Samples With DNA
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): NCT02589548
|Contact: Nelson Spector, MDemail@example.com|
|Contact: Irene Biasoli, MDfirstname.lastname@example.org|
|Universidade Federal Do Rio de Janeiro||Recruiting|
|Rio de Janeiro, Brazil, 21941-913|
|Contact: IRENE BIASOLI, MD 552139382460 email@example.com|
|Sub-Investigator: NELSON CASTRO, MD|
|Sub-Investigator: MARCIA DELAMAIN, MD|
|Sub-Investigator: RAFAEL GAIOLLA, MD|
|Sub-Investigator: BELINDA SIMÕES, MD|
|Sub-Investigator: CRISTIANA SOLZA, MD|
|Sub-Investigator: CARLOS CHIATTONE, MD|
|Sub-Investigator: CAROLINE BONAMIN, MD|
|Sub-Investigator: NELMA CLEMENTINO, MD|
|Sub-Investigator: MONICA PRAXEDES, MD|
|Sub-Investigator: CARLA BOQUIMPANI, MD|
|Sub-Investigator: OTAVIO BAIOCCHI, MD|
|Sub-Investigator: JAMES FARLEY, MD|
|Sub-Investigator: CARMINO DE SOUZA, MD|
|Sub-Investigator: KATIA PAGNANO, MD|
|Study Chair:||Nelson Spector, MD||UFRJ|
|Principal Investigator:||Irene Biasoli||UFRJ|