Clinical trial NCT04311060: Genetic and Molecular Characteristics of Mexican Adults With Acute Myeloid Leukemia: a Prospective Multicentric Study.
Official title: Genetic and Molecular Characteristics of Mexican Adults With Acute Myeloid Leukemia: a Prospective Multicenter Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Acute Myeloid Leukemia
Lead sponsor: Mexican Agrupation for Hematology Study
Sponsor class: OTHER
Collaborators: name: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
name: Instituto Nacional de Cancerologia de Mexico
name: Centro Medico Nacional Siglo XXI IMSS
name: Hospital General de México Dr. Eduardo Liceaga
name: Hospital Regional de Alta Especialidad del Bajio
name: Instituto Mexicano del Seguro Social
name: Hospital Universitario Dr. Jose E. Gonzalez
name: Hospital Regional de Alta Especialidad de Ciudad Victoria Bicentenario 2010
name: Hospital Juarez de Mexico
name: Hospital Regional de Alta especialidad de Ixtapaluca
First posted: 2020-03-17
Enrollment: 100
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Mexican adults with newly diagnosed AML who are candidates for treatment (intensive or not intensive)

Brief 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


Eligibility criteria: 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

Primary outcomes:
measure: overall survival
timeFrame: 3 year
Secondary outcomes:
Other outcomes:
Locations:
city: Ixtapaluca
country: Mexico
facility: Hospital Regional de Alta Especialidad Ixtapaluca
state: Edo Mex
city: León
country: Mexico
facility: Hospital Regional de Alta Especialidad Bajío
state: Guanajuato
city: Monterrey
country: Mexico
facility: Hospital Universitario
state: Nuevo León
city: Monterrey
country: Mexico
facility: Imss Umae 25
state: Nuevo León
city: Ciudad Victoria
country: Mexico
facility: Hospital Regional de Alta Especialidad Ciudad Victoria
state: Tamaulipas
city: Mexico City
country: Mexico
facility: Centro Médico Naciona Siglo XXI IMSS
city: Mexico City
country: Mexico
facility: Hospital General de México
city: Mexico City
country: Mexico
facility: Hospital Juarez de México
city: Mexico City
country: Mexico
facility: Instituto Nacional de Cancerlogía
city: Mexico Distrito Federal
country: Mexico
facility: Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Study officials:
References: