Brazilian Network for Lymphoma Registry

Recruiting

• Conditions: Lymphoma

• Registration Number: NCT02265497
• Lead Sponsor: Claudio Gustavo Stefanoff

Brief Summary

Currently there are no official data concerning incidence, progression and prognosis of patients with lymphoma in Brazil.This project aims the establishment of a network of 12 Brazilian Institutions to implement a Lymphoma Registry (RELINFO) with the Brazilian National Cancer Institute (INCA) as the Coordinating Center.We intend to develop and implement a computerized system for data entry and information management of patients with lymphomas. This will enable create a virtual registry of demographic, clinical, epidemiological, histopathological, molecular, and therapeutic data. This clinical record must be linked to histopathological and molecular diagnosis, allowing institutions that work in the context of the public health system have access to new technologies for early cancer diagnosis.We expect is that this record reliably portrays the scene of lymphomas in our state and will become a management model that can be replicated at the national level. Thus, the implementation of RELINFO will strengthen the multidisciplinary diagnosis, promote the standardization of clinical record of patients with lymphomas and provide subsidies to cooperative research projects between participating institutions.

Detailed Description

Data collection and management:

For data collection will use a common system for all institutions participating.We developed a computerized tool that utilizes models of case report forms (CRF) and allows the inclusion and management of clinical, epidemiological, histopathological and molecular data. The clinical and laboratory data of patients included in RELINFO will be obtained from the hospital records. The integration of local databases allows constitute the RELINFO, conceived as a virtual database of patients with lymphoma. The INCA as Coordinating Center is committed to the security of this database.Standardization of diagnosisThis phase includes structuring a technological platform for the standardization of histopathologic diagnosis (establishing common routines in hematopathology) and the incorporation of molecular methods in the diagnosis of lymphoma.

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-09-18
• Study First Submitted QC: 2014-10-15
• Study First Posted: 2014-10-16
• Status Verified: 2016-08
• Last Update Submitted: 2017-08-15
• Last Update Posted: 2017-08-18
• Primary Completion: 2018-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 550

Inclusion Criteria

• All patients (adult or child) with diagnosis of Hodgkin's or non-Hodgkin lymphoma with available with available clinical, histopathology and treatment data
• Patient enrolled on study sites included on this project

Exclusion Criteria

• Patients (adult or child) with other diagnoses of cancer

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
rate of incidence of lymphomas in Brazil	6 years	Identify the current situation of lymphomas, through the deployment of a Lymphoma Registry in cancer treatment centers of Rio de Janeiro, Brazil

Secondary Outcome Measures

Name	Time	Method
epidemiological characterization of lymphomas in Brazil	6 years	description of demographic, clinical, epidemiological, histopathological, molecular, and therapeutic data of lymphoma patients
establishing common routines in hematopathology	6 years	Structure a technology platform that allows the standardization of histopathological diagnosis and the incorporation of molecular methods in the diagnosis of lymphoma.

Trial Locations

Locations (1)

Brazilian National Cancer Institute - INCA/ Ministry Of HealthClinical Research Department; 🇧🇷 Rio de Janeiro, RJ, Brazil