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

NCT04311060 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2020-03-17

No results posted yet for this study

Summary

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

Conditions

Interventions

DIAGNOSTIC_TEST

Molecular panel

* Detection of CBF rearrangements using PCR: CBFB-MYH11 \[inv(16)(p13;q22), isoforms A, E and D; AML-ETO (RUNX1-RUNX1T1) (t8;21)(q22;q22). * NGS panel to detect classic mutations in: FLT3-ITD and TKD, NPM1, CEBPA, RUNX1, TP53, ASXL1, IDH1, IDH2 and KIT

Sponsors & Collaborators

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    collaborator OTHER
  • Instituto Nacional de Cancerologia de Mexico

    collaborator OTHER
  • Centro Medico Nacional Siglo XXI IMSS

    collaborator OTHER
  • Hospital General de México Dr. Eduardo Liceaga

    collaborator OTHER_GOV
  • Hospital Regional de Alta Especialidad del Bajio

    collaborator OTHER
  • Instituto Mexicano del Seguro Social

    collaborator OTHER_GOV
  • Hospital Universitario Dr. Jose E. Gonzalez

    collaborator OTHER
  • Hospital Regional de Alta Especialidad de Ciudad Victoria Bicentenario 2010

    collaborator OTHER
  • Hospital Juarez de Mexico

    collaborator OTHER_GOV
  • Hospital Regional de Alta especialidad de Ixtapaluca

    collaborator OTHER
  • Mexican Agrupation for Hematology Study

    lead OTHER

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-22
Primary Completion
2025-09-30
Completion
2025-10-31

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04311060 on ClinicalTrials.gov