Genetic and Molecular Characteristics of Mexican Adults With Acute Myeloid Leukemia: a Prospective Multicentric Study.

March 13, 2020 updated by: Mexican Agrupation for Hematology Study

Genetic and Molecular Characteristics of Mexican Adults With Acute Myeloid Leukemia: a Prospective Multicenter Study

Newly diagnosed adults patients with Acute Myeloid Leukemia will be assessed as traditionally by the treating institution using classic clinical, demographic and cytogenetic variables. Complementary molecular tests will be performed in the patients included in the study using PCR to detect classic CBF (Core Binding Factor) rearrangements: CBFB-MYH11 [inv(16)(p13;q22), isoforms A, E and D; AML-ETO (RUNX1-RUNX1T1) (t8;21)(q22;q22). NGS (Next Generation Sequencing) to detect mutations in: FLT3-ITD and TKD, NPM1, CEBPA, RUNX1, TP53, ASXL1, IDH1, IDH2 and KIT

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Mexico
      • Mexico City, Mexico
        • Hospital General de Mexico
        • Contact:
          • Efreen Montaño Figueroa, MD
      • Mexico City, Mexico
        • Centro Médico Naciona Siglo XXI IMSS
        • Contact:
          • Sue Cynthia Gómez Cortes, MD
      • Mexico City, Mexico
        • Hospital Juárez de México
        • Contact:
          • Andrea Milan Salvatierra, MD
      • Mexico City, Mexico
        • Instituto Nacional de Cancerlogía
        • Contact:
          • Silvia Rivas Vera, MD
      • Mexico Distrito Federal, Mexico, 1400
        • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
    • Edo Mex
      • Ixtapaluca, Edo Mex, Mexico
        • Hospital Regional de Alta Especialidad Ixtapaluca
        • Contact:
          • Álvaro Cabrera Garciá, MD
    • Guanajuato
      • León, Guanajuato, Mexico
        • Hospital Regional de Alta Especialidad Bajío
        • Contact:
          • Lauro Fabián Amador Medina, MD
    • Nuevo León
      • Monterrey, Nuevo León, Mexico
        • Hospital Universitario
        • Contact:
          • Andrés Gómez, MD
      • Monterrey, Nuevo León, Mexico
        • Imss Umae 25
        • Contact:
          • Diego Cruz Contreras, MD
    • Tamaulipas
      • Ciudad Victoria, Tamaulipas, Mexico
        • Hospital Regional de Alta Especialidad Ciudad Victoria
        • Contact:
          • Ramón A Martínez Hernández, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Mexican adults with newly diagnosed AML who are candidates for treatment (intensive or not intensive)

Description

Inclusion Criteria:

  • Newly diagnosed AML
  • Over 15 years of age
  • Flow cytometry confirmation
  • Candidate for treatment (intensive or not intensive)

Exclusion Criteria:

  • Acute Promyelocytic Leukemia
  • Mixed phenotype leukemias
  • Isolated myeloid sarcoma
  • Blastic plasmacytoid dendritic cell neoplasm

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: 3 year
3 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mexican Agrupation for Hematology Study

Collaborators

Instituto Mexicano del Seguro Social
Hospital Universitario Dr. Jose E. Gonzalez
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Hospital Regional de Alta especialidad de Ixtapaluca
Instituto Nacional de Cancerologia de Mexico
Hospital General de México Dr. Eduardo Liceaga
Hospital Juarez de Mexico
Hospital Regional de Alta Especialidad del Bajio
Centro Medico Nacional Siglo XXI IMSS
Hospital Regional de Alta Especialidad de Ciudad Victoria Bicentenario 2010

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 22, 2020

Primary Completion (Anticipated)

September 30, 2025

Study Completion (Anticipated)

October 31, 2025

Study Registration Dates

First Submitted

March 13, 2020

First Submitted That Met QC Criteria

March 13, 2020

First Posted (Actual)

March 17, 2020

Study Record Updates

Last Update Posted (Actual)

March 17, 2020

Last Update Submitted That Met QC Criteria

March 13, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HEM-3094-19-25-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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