Brazilian Prospective Hodgkin Lymphoma Registry

May 16, 2022 updated by: Irene Biasoli, Universidade Federal do Rio de Janeiro

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

1400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Nelson Spector, MD
  • Phone Number: +552139382460
  • Email: spector@ufrj.br

Study Contact Backup

Study Locations

  • Brazil
      • Rio de Janeiro, Brazil, 21941-913
        • Recruiting
        • Universidade Federal do Rio de Janeiro
        • Contact:
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 98 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hodgkin Lymphoma patients

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: 5 years
Overall Survival
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event Free survival
Time Frame: 5 years
Event free survival
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal do Rio de Janeiro

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

October 26, 2015

First Submitted That Met QC Criteria

October 26, 2015

First Posted (Estimate)

October 28, 2015

Study Record Updates

Last Update Posted (Actual)

May 17, 2022

Last Update Submitted That Met QC Criteria

May 16, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RBLH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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