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

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Acute myelomonocytic leukemia
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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