LymphomaRelinfoNCT02265497
Brazilian Network for Lymphoma Registry
An observational study of Lymphoma, run by Claudio Gustavo Stefanoff at 1 site in Brazil.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lymphoma
- How many people
- 550 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2014to Dec 2025
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with diagnosis of Hodgkin's or non-Hodgkin lymphoma with available with available clinical, histopathology and treatment data.
Who may be able to join
- 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
Who cannot join
- Patients (adult or child) with other diagnoses of cancer
Trial locations and contacts
1 site in 1 country.
Claudio Gustavo Stefanoff, doctor contact
Cecilia F Silva, Master contact
Brazil1 site, 1 recruiting
- Recruiting
Brazilian National Cancer Institute - INCA/ Ministry Of HealthClinical Research Department
Rio de Janeiro, Rio de Janeiro, 20231-050
Claudio Gustavo Stefanoof, Doctor, +55 21 32076541
Adriana A Scheliga, Master, +55 21 32076585
About this study
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.
Read the 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.
- Conditions
- Lymphoma
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 years
Secondary outcomes (2)
epidemiological characterization of lymphomas in Brazil
description of demographic, clinical, epidemiological, histopathological, molecular, and therapeutic data of lymphoma patients
Measured: 6 years
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.
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2014 (estimated)
- Study startMar 2014
- Primary completionDec 2018 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 550 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Claudio Gustavo Stefanoff
- Sponsor type
- Other government
- 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
- Responsible party
- Sponsor-investigator, Claudio Gustavo Stefanoff, Instituto Nacional de Cancer, Brazil
- Investigators
- Claudio Gustavo Stefanoff, Doctor, Study director, Instituto Nacional de Cancer, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02265497
- Sponsor's protocol ID
- Relinfo
- Acronym
- Relinfo
- Status last verified
- Aug 2016
- First submitted
- 18 Sep 2014
- Last updated
- 18 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brazilian Network for Lymphoma Registry
- ClinicalTrials.gov ID
- NCT02265497
- Acronym / sponsor ID
- Relinfo / Relinfo
- Conditions
- Lymphoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- Claudio Gustavo StefanoffOther government
- 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
- Study start
- Mar 2014
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 16 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with diagnosis of Hodgkin's or non-Hodgkin lymphoma with available with available clinical, histopathology and treatment data.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Patients (adult or child) with other diagnoses of cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
epidemiological characterization of lymphomas in Brazil
Time frame: 6 years
establishing common routines in hematopathology
Time frame: 6 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2017.
Related trials for Lymphoma
RecruitingPhase 2/3
A Clinical Trial of MK-1045 in People With B-cell Acute Lymphoblastic Leukemia (MK-1045-005)
B-cell Acute Lymphoblastic Leukemia
Active, not recruitingPhase 1/2
Tafasitamab, Retifanlimab, and Rituximab in Combination With Standard Therapy for the Treatment of Diffuse Large B-cell Lymphoma
Diffuse Large B-Cell Lymphoma, Grade 3b Follicular Lymphoma
Enrolling by invitationPhase 2
Tau PET Outcomes With Anti-amyloid Immunotherapies
Cognitive Impairment, Mild, Dementia, Mild
RecruitingPhase 1
225Ac-DOTA-Anti-CD38 Daratumumab Monoclonal Antibody With Fludarabine, Melphalan and Total Marrow and Lymphoid Irradiation as Conditioning Treatment for Donor Stem Cell Transplant in Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia and Myelodysplastic Syndrome
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
Recruiting
More Than Just X-Rays - Imaging of Chemotherapy-induced Morphological and Functional Cardiovascular and Lung Changes After Childhood ALL and Other Cancers - a Monocentric Late Effects Study (MaximALL)
Acute Lymphatic Leukemia, Lymphoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudio Gustavo Stefanoff, doctor contact
Cecilia F Silva, Master contact
Claudio Gustavo Stefanoff, Doctor study director
Instituto Nacional de Cancer, Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoma, run by Claudio Gustavo Stefanoff at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Claudio Gustavo Stefanoff, doctor (+55 21 32076541), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of incidence of lymphomas in Brazil (time frame: 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2017.