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Brazilian Prospective Hodgkin Lymphoma Registry

Brazilian Prospective Hodgkin Lymphoma Registry

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02589548
Enrollment
1400
Registered
2015-10-28
Start date
2009-10-31
Completion date
2022-12-31
Last updated
2022-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hodgkin Disease, Hodgkin Lymphoma

Keywords

Hodgkin Lymphoma, Hodgkin Disease

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.

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.

Interventions

None listed

Sponsors

Universidade Federal do Rio de Janeiro
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
12 Years to 100 Years
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

\-

Design outcomes

Primary

MeasureTime frameDescription
Overall Survival5 yearsOverall Survival

Secondary

MeasureTime frameDescription
Event Free survival5 yearsEvent free survival

Countries

Brazil

Contacts

Primary ContactNelson Spector, MD
spector@ufrj.br+552139382460
Backup ContactIrene Biasoli, MD
irene.biasoli@gmail.com+552139382460

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026