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First Report, Five Years Experience of the Acute Leukemia Work Group (PR-GTLA)

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: NCT02990104
Recruitment Status : Unknown
Verified November 2016 by Mexican Agrupation for Hematology Study.
Recruitment status was:  Recruiting
First Posted : December 13, 2016
Last Update Posted : December 13, 2016
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Mexican Agrupation for Hematology Study

Brief 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.

Condition or disease
Acute Leukemia (Category)

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Retrospective
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)
Study Start Date : November 2016
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : July 2017





Primary Outcome Measures :
  1. Get the incidence of Acute Lymphoblastic Leukemia in Mexico City reference hospitals [ Time Frame: 5 years ]
    Date collection from clinical files with Acute Lymphoblastic Leukemia diagnostic between 2009 and 2013 in Mexico City in 5 reference hospitals


Secondary Outcome Measures :
  1. Clinic characteristics, biological and survival in Acute Lymphoblastic Leukemia patients in Mexico City reference hospitals [ Time Frame: 5 years ]
    Date collection from clinical files with Acute Lymphoblastic Leukemia diagnostic between 2009 and 2013 in Mexico City in 5 reference hospitals



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Acute Lymphoblastic Leukemia
Criteria

Inclusion Criteria:

  • Clinical diagnosis of Acute Lymphoblastic Leukemia

Exclusion Criteria none


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): NCT02990104


Contacts
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Contact: Dra. Roberta Demichelis, Doctor 015554870900 ext 2700 robertademichelis@gmail.com
Contact: Dra. Karla Espinoza, Doctor 015556280400

Locations
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Mexico
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán Recruiting
Mexico Distrito Federal, Mexico, 1400
Contact: Roberta Demichelis, Doctor    015554870900 ext 2700    robertademichelis@gmail.com   
Contact: Karla Espinoza, Doctor    015556280400 ext 60035      
Sponsors and Collaborators
Mexican Agrupation for Hematology Study
Amgen
Investigators
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Principal Investigator: Dr. Erick Crespo, Doctor Regional Hospital High Speciality, Tamaulipas Cd. Victoria
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Responsible Party: Mexican Agrupation for Hematology Study
ClinicalTrials.gov Identifier: NCT02990104    
Other Study ID Numbers: 2016001/PR-GTLA
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: December 13, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Leukemia
Acute Disease
Neoplasms by Histologic Type
Neoplasms
Disease Attributes
Pathologic Processes