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T-cell Brazil: Prospective Collection of Data in T-cell Lymphomas Patients

Prospective Collection of Data in Patients With T-cell Lymphomas Distributed in the Five Distinct Macro Regions of Brazil

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03207789
Acronym
Tcell-Brazil
Enrollment
500
Registered
2017-07-05
Start date
2015-01-01
Completion date
2020-12-31
Last updated
2017-07-05

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

Conditions

NK-Cell Lymphoma, T-cell Lymphoma, T-cell Lymphoma Adults

Brief summary

The designed study follows up on the previous one by the international T-cell project (Bellei et al,, 2012) and its purpose is to verify whether a prospective collection of data would permit access to more accurate information permitting a better definition of prognosis and investigation of more adequate treatment strategies for these neoplasms. The analysis of patients distributed in all five macro regions of the country and a comparison among them will provide a real picture of the disease in Brazil, limiting the bias probably found in the previous projects.

Detailed description

Patients with diagnosis histologically confirmed T-cell or NK-cell lymphoma will be registered in the study, despite of their planned treatment. Registration will be made on-line on a key restricted accessible web-database after obtaining the informed consent dated and signed by the patient. Every registered patient has as well to undergo a central histopathology review by a panel of experts. The referring pathologist will collect and review the patological material sent by the participating centers, without knowing the clinical outcome of the patient. Validated cases have to be supplied of information regarding treatment procedures and follow up updating for at least 5 years. The primary endpoint is the overall survival and other endpoints such as event free survival; progression free survival, complete and partial response rates.

Interventions

None listed

Sponsors

Takeda
CollaboratorINDUSTRY
Grupo de Estudos Multicentricos em Onco-Hematologia
Lead SponsorNETWORK

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* Dated and signed informed consent; * T-cell or NK-cell diagnosis; * Tissue biopsies adequate for diagnosis and classification and available for centralized review; * clinical, laboratory, image data available and registred in the website.

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
Descriptive analysis during the first year of T-cell Brazil Registry12 months of registringDescriptive analysis and Overall survival

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026