Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 4 for:    T cell Brazil project
Previous Study | Return to List | Next Study

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

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.


Condition or disease
T-cell Lymphoma NK-Cell Lymphoma T-cell Lymphoma Adults

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.

Layout table for study information
Study Type : Observational [Patient Registry]
Actual Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 5 Years
Official Title: Prospective Collection of Data in Patients With T-cell Lymphomas Distributed in the Five Distinct Macro Regions of Brazil
Actual Study Start Date : January 1, 2015
Actual Primary Completion Date : June 1, 2017
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma




Primary Outcome Measures :
  1. Descriptive analysis during the first year of T-cell Brazil Registry [ Time Frame: 12 months of registring ]
    Descriptive analysis and Overall survival



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03207789


Sponsors and Collaborators
Grupo de Estudos Multicentricos em Onco-Hematologia
Takeda
Investigators
Layout table for investigator information
Study Chair: Eliana CM Miranda, M.Ed.; Ph.D. Grupo de Estudos Multicentricos em Onco-Hematologia

Additional Information:

Layout table for additonal information
Responsible Party: Grupo de Estudos Multicentricos em Onco-Hematologia
ClinicalTrials.gov Identifier: NCT03207789     History of Changes
Other Study ID Numbers: CAAE: 69605517.1.1001.5487
First Posted: July 5, 2017    Key Record Dates
Last Update Posted: July 5, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma
Lymphoma, T-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin