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

NCT ID: NCT03207789

Last Updated: 2017-07-05

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-01
• Study Completion Date: 2020-12-31

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.

Conditions

T-cell Lymphoma; NK-Cell Lymphoma; T-cell Lymphoma Adults

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

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

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: collaborator

Grupo de Estudos Multicentricos em Onco-Hematologia

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eliana CM Miranda, M.Ed.; Ph.D.

Role: STUDY_CHAIR

Grupo de Estudos Multicentricos em Onco-Hematologia

Other Identifiers

CAAE: 69605517.1.1001.5487

Identifier Type: -

Identifier Source: org_study_id