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

T-cell Lymphoma Clinical Trial

— Tcell-Brazil  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03207789
• Other study ID #: CAAE: 69605517.1.1001.5487
• Status: Enrolling by invitation
• Phase: N/A
• First received: June 30, 2017
• Last updated: June 30, 2017
• Start date: January 1, 2015
• Est. completion date: December 31, 2020

Study information

• Verified date: June 2017
• Source: Grupo de Estudos Multicentricos em Onco-Hematologia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 500
• Est. completion date: December 31, 2020
• Est. primary completion date: June 1, 2017
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Grupo de Estudos Multicentricos em Onco-Hematologia	Takeda

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Descriptive analysis during the first year of T-cell Brazil Registry	Descriptive analysis and Overall survival	12 months of registring