Clinical trial NCT02589548: Brazilian Prospective Hodgkin Lymphoma Registry
Official title: Brazilian Prospective Hodgkin Lymphoma Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hodgkin Lymphoma
Hodgkin Disease
Keywords: Hodgkin Lymphoma
Hodgkin Disease
Lead sponsor: Universidade Federal do Rio de Janeiro
Sponsor class: OTHER
First posted: 2015-10-28
Enrollment: 1400
Sex: ALL
Minimum age (years): 12
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hodgkin Lymphoma patients

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.

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:

-

Primary outcomes:
measure: Overall Survival
timeFrame: 5 years
Secondary outcomes:
measure: Event Free survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Universidade Federal Do Rio de Janeiro
Study officials:
affiliation: UFRJ
name: Nelson Spector, MD
role: STUDY_CHAIR
affiliation: UFRJ
name: Irene Biasoli
role: PRINCIPAL_INVESTIGATOR
References: