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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
Sponsor:
Information provided by (Responsible Party):
Irene Biasoli, Universidade Federal do Rio de Janeiro

Brief 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.


Condition or disease
Hodgkin Lymphoma Hodgkin Disease

Detailed 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.


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Study Type : Observational
Estimated Enrollment : 1400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Brazilian Prospective Hodgkin Lymphoma Registry
Study Start Date : October 2009
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Overall Survival [ Time Frame: 5 years ]
    Overall Survival


Secondary Outcome Measures :
  1. Event Free survival [ Time Frame: 5 years ]
    Event free survival


Biospecimen Retention:   Samples With DNA
Formalin-fixed tissue for central diagnostic pathology review


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hodgkin Lymphoma patients
Criteria

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:

-


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): NCT02589548


Contacts
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Contact: Nelson Spector, MD +552139382460 spector@ufrj.br
Contact: Irene Biasoli, MD +552139382460 irene.biasoli@gmail.com

Locations
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Brazil
Universidade Federal Do Rio de Janeiro Recruiting
Rio de Janeiro, Brazil, 21941-913
Contact: IRENE BIASOLI, MD    552139382460    irene.biasoli@gmail.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         
Sponsors and Collaborators
Universidade Federal do Rio de Janeiro
Investigators
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Study Chair: Nelson Spector, MD UFRJ
Principal Investigator: Irene Biasoli UFRJ

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Responsible Party: Irene Biasoli, Associate Professor, Universidade Federal do Rio de Janeiro
ClinicalTrials.gov Identifier: NCT02589548     History of Changes
Other Study ID Numbers: RBLH
First Posted: October 28, 2015    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019

Keywords provided by Irene Biasoli, Universidade Federal do Rio de Janeiro:
Hodgkin Lymphoma
Hodgkin Disease

Additional relevant MeSH terms:
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Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases