Brazilian Network for Lymphoma Registry

Lymphoma Clinical Trial

— Relinfo  

Official title:

Brazilian Network for Lymphoma Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02265497
• Other study ID #: Relinfo
• Status: Recruiting
• Phase: N/A
• First received: September 18, 2014
• Last updated: August 15, 2017
• Start date: March 2014
• Est. completion date: December 2025

Study information

• Verified date: August 2016
• Source: Instituto Nacional de Cancer, Brazil
• Contact: Claudio Gustavo Stefanoff, doctor
• Phone: +55 21 32076541
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 550
• Est. completion date: December 2025
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma

Locations

Country	Name	City	State
Brazil	Brazilian National Cancer Institute - INCA/ Ministry Of HealthClinical Research Department	Rio de Janeiro	RJ

Sponsors (9)

Lead Sponsor	Collaborator
Claudio Gustavo Stefanoff	Adriana Alves de Souza Scheliga, Cecilia Ferreira da Silva, Claudete Esteves Nogueira Pinto Klumb, Isabele Avila Small, Luciana Wernersbach Pinto, Monik Mariano Pinto, Ricardo de Sá Bigni, Rocio Hassan

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of incidence of lymphomas in Brazil	Identify the current situation of lymphomas, through the deployment of a Lymphoma Registry in cancer treatment centers of Rio de Janeiro, Brazil	6 years
Secondary	epidemiological characterization of lymphomas in Brazil	description of demographic, clinical, epidemiological, histopathological, molecular, and therapeutic data of lymphoma patients	6 years
Secondary	establishing common routines in hematopathology	Structure a technology platform that allows the standardization of histopathological diagnosis and the incorporation of molecular methods in the diagnosis of lymphoma.	6 years