Clinical trial NCT02265497: Brazilian Network for Lymphoma Registry
Official title: Brazilian Network for Lymphoma Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lymphoma
Lead sponsor: Instituto Nacional de Cancer, Brazil
Sponsor class: OTHER_GOV
Collaborators: name: Adriana Alves de Souza Scheliga
name: Claudete Esteves Nogueira Pinto Klumb
name: Ricardo de Sá Bigni
name: Luciana Wernersbach Pinto
name: Rocio Hassan
name: Isabele Avila Small
name: Monik Mariano Pinto
name: Cecilia Ferreira da Silva
First posted: 2014-10-16
Enrollment: 550
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: rate of incidence of lymphomas in Brazil
timeFrame: 6 years
Secondary outcomes:
measure: epidemiological characterization of lymphomas in Brazil
timeFrame: 6 years
measure: establishing common routines in hematopathology
timeFrame: 6 years
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Brazilian National Cancer Institute - INCA/ Ministry Of HealthClinical Research Department
state: RJ
Study officials:
affiliation: Instituto Nacional de Cancer, Brazil
name: Claudio Gustavo Stefanoff, Doctor
role: STUDY_DIRECTOR
References: