NCT03207789

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

June 30, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 5, 2017

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

July 5, 2017

Status Verified

June 1, 2017

Enrollment Period

2.4 years

First QC Date

June 30, 2017

Last Update Submit

June 30, 2017

Conditions

T-cell LymphomaNK-Cell LymphomaT-cell Lymphoma Adults

Outcome Measures

Primary Outcomes (1)

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

    Descriptive analysis and Overall survival

    12 months of registring

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with confirmed histologically diagnosis of T-cell or NH-cell lymphoma in any of 5 macro region of Brazil

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lymphoma, T-Cell

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Eliana CM Miranda, M.Ed.; Ph.D.

    Grupo de Estudos Multicentricos em Onco-Hematologia

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
5 Years
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2017

First Posted

July 5, 2017

Study Start

January 1, 2015

Primary Completion

June 1, 2017

Study Completion

December 31, 2020

Last Updated

July 5, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share