Brief Title
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
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
Study Type
Observational [Patient Registry]
Primary Outcome
overall survival
Condition
Acute Myeloid Leukemia
Intervention
Molecular panel
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Diagnostic Test
Estimated Enrollment
100
Start Date
March 22, 2020
Completion Date
October 31, 2025
Primary Completion Date
September 30, 2025
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
Gender
All
Ages
15 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, +521555487 0900, [email protected]
Location Countries
Mexico
Location Countries
Mexico
Administrative Informations
NCT ID
NCT04311060
Organization ID
HEM-3094-19-25-1
Responsible Party
Sponsor
Study Sponsor
Mexican Agrupation for Hematology Study
Collaborators
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Study Sponsor
, ,
Verification Date
March 2020