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

• Conditions: T-cell Lymphoma; T-cell Lymphoma Adults; NK-Cell Lymphoma

• Registration Number: NCT03207789
• Lead Sponsor: Grupo de Estudos Multicentricos em Onco-Hematologia

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.

Study Timeline

• Study Start: 2015-01-01
• Status Verified: 2017-06
• Primary Completion: 2017-06-01
• Study First Submitted: 2017-06-30
• Study First Submitted QC: 2017-06-30
• Last Update Submitted: 2017-06-30
• Study First Posted: 2017-07-05
• Last Update Posted: 2017-07-05
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Descriptive analysis during the first year of T-cell Brazil Registry	12 months of registring	Descriptive analysis and Overall survival