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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04311060
Enrollment
100
Registered
2020-03-17
Start date
2020-03-22
Completion date
2025-10-31
Last updated
2020-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia

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

Interventions

DIAGNOSTIC_TESTMolecular 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

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
overall survival3 year

Countries

Mexico

Contacts

Primary ContactRoberta Demichelis, MD
robertademichelis@gmail.com+521555487 0900
Backup ContactEmmanuel Almanza Huante, MD
ealmanza.huante@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026