Brazilian Prospective Hodgkin Lymphoma Registry

Sponsor
Universidade Federal do Rio de Janeiro (Other)
Overall Status
Recruiting
CT.gov ID
NCT02589548
Collaborator
(none)
1,400
1
158
8.9

Study Details

Study Description

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 Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1400 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Brazilian Prospective Hodgkin Lymphoma Registry
    Study Start Date :
    Oct 1, 2009
    Anticipated Primary Completion Date :
    Dec 1, 2022
    Anticipated Study Completion Date :
    Dec 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Overall Survival [5 years]

      Overall Survival

    Secondary Outcome Measures

    1. Event Free survival [5 years]

      Event free survival

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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:

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Universidade Federal Do Rio de Janeiro Rio de Janeiro Brazil 21941-913

    Sponsors and Collaborators

    • Universidade Federal do Rio de Janeiro

    Investigators

    • Study Chair: Nelson Spector, MD, UFRJ
    • Principal Investigator: Irene Biasoli, UFRJ

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Irene Biasoli, Associate Professor, Universidade Federal do Rio de Janeiro
    ClinicalTrials.gov Identifier:
    NCT02589548
    Other Study ID Numbers:
    • RBLH
    First Posted:
    Oct 28, 2015
    Last Update Posted:
    May 17, 2022
    Last Verified:
    May 1, 2022
    Keywords provided by Irene Biasoli, Associate Professor, Universidade Federal do Rio de Janeiro
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 17, 2022