Brazilian Prospective Hodgkin Lymphoma Registry

NCT ID: NCT02589548

Last Updated: 2022-05-17

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2022-12-31

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.

Conditions

Hodgkin Lymphoma; Hodgkin Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility 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

-

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Federal do Rio de Janeiro

OTHER

Sponsor Role: lead

Responsible Party

Irene Biasoli

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nelson Spector, MD

Role: STUDY_CHAIR

UFRJ

Irene Biasoli

Role: PRINCIPAL_INVESTIGATOR

UFRJ

Locations

Universidade Federal Do Rio de Janeiro

Rio de Janeiro, , Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Nelson Spector, MD

Role: CONTACT

spector@ufrj.br

+552139382460

Irene Biasoli, MD

Role: CONTACT

irene.biasoli@gmail.com

+552139382460

Facility Contacts

IRENE BIASOLI, MD

Role: primary

irene.biasoli@gmail.com

552139382460

Other Identifiers

RBLH

Identifier Type: -

Identifier Source: org_study_id