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Data collection of patients with diagnostic of T-cell Lymphoma in the five regions in Brazil

T-cell Brazil Project: prospective collection of data in patients with T-cell Lymphomas distributed in the five distinct macro regions in Brazil

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
REBEC
Registry ID
RBR-58jj2j
Enrollment
Unknown
Registered
2018-02-05
Start date
2015-01-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant neoplasms (malign tumors) called T-cell Lymphoma, peripherical, T zone Lymphoma.

Interventions

An analytical, transversal, observational study where it is expected to enroll about 500 patients. Demographic data, diagnosis, treatment, response every 6 months, whether relapse or progression, re-t
Other

Sponsors

Hospital Samaritano de Sao Paulo Ltda
Lead Sponsor
GEMOH- Grupo de estudos multicentricos em onco-hematologia
Collaborator
Hemocentro-Unicamp (Centro de Hematologia e Hemoterapia da Universidade Estadual de Campinas)
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Date of diagnosis from January, 2015, Newly diagnosed patients with T-cell or T/NK cell peripherical lymphomas; tissue biopsies adequate for diagnosis and classification, all available for centralizes review; clinical data including baseline information on disease localization and laboratory parameters at staging, features on treatment adopted and assurance of follow up updating for at least 5 years are requested. Besides that, dated and signed consent form.

Exclusion criteria

Exclusion criteria: If diagnosis of Blastic NK-cell leukemia/lymphoma; Aggressive NK-cell leukemia; T-cell large granular lymphocytic leukemia; T-cell large granular lymphocytic proliferation; NK-cell large granular lymphocytic proliferation; T-cell prolymphocytic leukemia; Precursor T-cell lymphoblastic leukemia/lymphoma; mycosis fungoides; sézary syndrome; primary cutaneous ALCL.

Design outcomes

Primary

MeasureTime frame
Expected Outcome 1. the 5-year overall survival. The overall survival (OS) will be based on date of diagnosis until follow-up date or date of death, in months. The event will be the death by any cause, whereas the othes will be censured in the last contact date. The Kaplan-Meier method and the Log-Rank test will be applied to check if there are differences among several stratification, such as, 5 Brazilian regions and different type of T-Cell lymphomas. This analyses will be done twice a year.

Secondary

MeasureTime frame
Expected outcome 2. Event free survival (EFS). The events for EFS will be the relapse, progression, toxicity caused by treatment and death by any cause. Kaplan-Meier method and the Log-Rank test will be applied to check if there are differences among several stratifications. This analyses will be done twice a year.;Expected outcome 3. Progression free survival (PFS). The events for PFS will be progression of disease and death caused by lymphoma. Kaplan-Meier method and the Log-Rank test will be applied to check if there are differences among several stratifications. This analyses will be done twice a year. ;Expected outcome 4. Rate of complete or partial response. Based on total number of patients will be calculated how many patients will get complete remission after first line treament. This analyses will be done twice a year.

Countries

Brazil

Contacts

Public ContactMarcia;Nicete Delamain;Romano

Hemocentro-Unicamp (Centro de Hematologia e Hemoterapia da Universidade Estadual de Campinas);Hemocentro-Unicamp (Centro de Hematologia e Hemoterapia da Universidade Estadual de Campinas)

marciatd@unicamp.br;nicete@unicamp.br+551935218740;+551935218740

Outcome results

None listed

Source: REBEC (via WHO ICTRP)