Brazilian Network for Lymphoma Registry (Relinfo)

August 15, 2017 updated by: Claudio Gustavo Stefanoff
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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

550

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: Claudio Gustavo Stefanoff, doctor
  • Phone Number: +55 21 32076541

Study Contact Backup

  • Name: Cecilia F Silva, Master
  • Phone Number: +55 21 32076601

Study Locations

  • Brazil
    • RJ
      • Rio de Janeiro, RJ, Brazil, 20231-050
        • Recruiting
        • Brazilian National Cancer Institute - INCA/ Ministry Of HealthClinical Research Department
        • Contact:
          • Claudio Gustavo Stefanoof, Doctor
          • Phone Number: +55 21 32076541
        • Contact:
          • Adriana A Scheliga, Master
          • Phone Number: +55 21 32076585
        • Principal Investigator:
          • Adilson José Almeida
        • Principal Investigator:
          • Monica Praxedes
        • Principal Investigator:
          • Fernando M Pinto
        • Principal Investigator:
          • Rita Elizabete G Espariz
        • Principal Investigator:
          • Luciana Conti
        • Principal Investigator:
          • Glaucia Guasti
        • Principal Investigator:
          • Juliana G Musacchio
        • Principal Investigator:
          • Leonardo G Leite

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients with diagnosis of Hodgkin's or non-Hodgkin lymphoma with available with available clinical, histopathology and treatment data.

Description

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 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

Cohorts and Interventions

Group / Cohort
Hodgkin's or non-Hodgkin lymphoma
All patients with diagnoses of Hodgkin's or non-Hodgkin lymphoma with available with available clinical, histopathology and treatment data.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rate of incidence of lymphomas in Brazil
Time Frame: 6 years
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 Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Claudio Gustavo Stefanoff

Collaborators

Adriana Alves de Souza Scheliga
Claudete Esteves Nogueira Pinto Klumb
Ricardo de Sá Bigni
Luciana Wernersbach Pinto
Rocio Hassan
Isabele Avila Small
Monik Mariano Pinto
Cecilia Ferreira da Silva

Investigators

  • Study Director: Claudio Gustavo Stefanoff, Doctor, Instituto Nacional de Cancer, Brazil

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

March 1, 2014

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

September 18, 2014

First Submitted That Met QC Criteria

October 15, 2014

First Posted (Estimate)

October 16, 2014

Study Record Updates

Last Update Posted (Actual)

August 18, 2017

Last Update Submitted That Met QC Criteria

August 15, 2017

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Relinfo

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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