First Report, Five Years Experience of the Acute Leukemia Work Group

Acute Leukemia (Category) Clinical Trial

— PR-GTLA  

Official title:

Diagnostic and Treatment in Acute Lymphoblastic Leukemia Adults: A Multicenter Study of Five Years Experience, Retrospective in Acute Lymphoblastic Leukemia Adults Patients, Mexico City: First Report of the Acute Leukemia Work Group (GTLA)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02990104
• Other study ID #: 2016001/PR-GTLA
• Status: Recruiting
• Phase: N/A
• First received: December 5, 2016
• Last updated: December 7, 2016
• Start date: November 2016
• Est. completion date: July 2017

Study information

• Verified date: November 2016
• Source: Mexican Agrupation for Hematology Study
• Contact: Dra. Roberta Demichelis, Doctor
• Phone: 015554870900
• Email: robertademichelis[@]gmail.com
• Is FDA regulated: No
• Health authority: Mexico: Secretaria de Salud
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to describe the incidence, clinic characteristics, biological and suvirval in Lymphoblastic Leukemia patients in Mexico City reference hospitals.

Description:

Multicenter and retrospective revision of clinical files with Acute Lymphoblastic Leukemia diagnostic between 2009 and 2013 in Mexico City reference hospitals, in five hospitals with 50 and 100 new cases Acute Lymphoblastic Leukemia per year. With a expected sample between 500 and 1000 patients it will descriptive statistics of variables. The data collection with necessary variables for survival analysis study and risk factors with Kaplan-Meier curve and risk proportional method Cox.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: July 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of Acute Lymphoblastic Leukemia

Exclusion Criteria none

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Acute Disease
• Acute Leukemia (Category)
• Leukemia
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán	Mexico Distrito Federal

Sponsors (2)

Lead Sponsor	Collaborator
Mexican Agrupation for Hematology Study	Amgen

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Get the incidence of Acute Lymphoblastic Leukemia in Mexico City reference hospitals	Date collection from clinical files with Acute Lymphoblastic Leukemia diagnostic between 2009 and 2013 in Mexico City in 5 reference hospitals	5 years	No
Secondary	Clinic characteristics, biological and survival in Acute Lymphoblastic Leukemia patients in Mexico City reference hospitals	Date collection from clinical files with Acute Lymphoblastic Leukemia diagnostic between 2009 and 2013 in Mexico City in 5 reference hospitals	5 years	No