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Trial record 1 of 4 for:    T cell Brazil project
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T-cell Brazil: Prospective Collection of Data in T-cell Lymphomas Patients (Tcell-Brazil)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03207789
Recruitment Status : Enrolling by invitation
First Posted : July 5, 2017
Last Update Posted : July 5, 2017
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
Grupo de Estudos Multicentricos em Onco-Hematologia

Tracking Information
First Submitted Date June 30, 2017
First Posted Date July 5, 2017
Last Update Posted Date July 5, 2017
Actual Study Start Date January 1, 2015
Actual Primary Completion Date June 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 30, 2017)
Descriptive analysis during the first year of T-cell Brazil Registry [ Time Frame: 12 months of registring ]
Descriptive analysis and Overall survival
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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]
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration 5 Years
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients with confirmed histologically diagnosis of T-cell or NH-cell lymphoma in any of 5 macro region of Brazil
Condition
  • T-cell Lymphoma
  • NK-Cell Lymphoma
  • T-cell Lymphoma Adults
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Actual Enrollment
 (submitted: June 30, 2017)
500
Original Actual Enrollment Same as current
Estimated Study Completion Date December 31, 2020
Actual Primary Completion Date June 1, 2017   (Final data collection date for primary outcome measure)
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:

-

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03207789
Other Study ID Numbers CAAE: 69605517.1.1001.5487
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Grupo de Estudos Multicentricos em Onco-Hematologia
Study Sponsor Grupo de Estudos Multicentricos em Onco-Hematologia
Collaborators Takeda
Investigators
Study Chair: Eliana CM Miranda, M.Ed.; Ph.D. Grupo de Estudos Multicentricos em Onco-Hematologia
PRS Account Grupo de Estudos Multicentricos em Onco-Hematologia
Verification Date June 2017