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

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Brief Title

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

Official Title

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

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 Type

Observational [Patient Registry]


Primary Outcome

Descriptive analysis during the first year of T-cell Brazil Registry


Condition

T-cell Lymphoma



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

500

Start Date

January 1, 2015

Completion Date

December 31, 2020

Primary Completion Date

June 1, 2017

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:

        -
      

Gender

All

Ages

18 Years - N/A


Contacts

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



Administrative Informations


NCT ID

NCT03207789

Organization ID

CAAE: 69605517.1.1001.5487


Responsible Party

Sponsor

Study Sponsor

Grupo de Estudos Multicentricos em Onco-Hematologia

Collaborators

 Takeda

Study Sponsor

Eliana CM Miranda, M.Ed.; Ph.D., Study Chair, Grupo de Estudos Multicentricos em Onco-Hematologia


Verification Date

June 2017