Genetic and Molecular Characteristics of Mexican Adults With Acute Myeloid Leukemia: a Prospective Multicentric Study.
March 13, 2020 updated by: Mexican Agrupation for Hematology Study
Genetic and Molecular Characteristics of Mexican Adults With Acute Myeloid Leukemia: a Prospective Multicenter Study
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 Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Roberta Demichelis, MD
- Phone Number: 2700 +521555487 0900
- Email: robertademichelis@gmail.com
Study Contact Backup
- Name: Emmanuel Almanza Huante, MD
- Email: ealmanza.huante@gmail.com
Study Locations
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Mexico City, Mexico
- Hospital General De Mexico
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Contact:
- Efreen Montaño Figueroa, MD
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Mexico City, Mexico
- Centro Médico Naciona Siglo XXI IMSS
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Contact:
- Sue Cynthia Gómez Cortes, MD
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Mexico City, Mexico
- Hospital Juárez de Mexico
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Contact:
- Andrea Milan Salvatierra, MD
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Mexico City, Mexico
- Instituto Nacional de Cancerlogía
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Contact:
- Silvia Rivas Vera, MD
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Mexico Distrito Federal, Mexico, 1400
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
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Edo Mex
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Ixtapaluca, Edo Mex, Mexico
- Hospital Regional de Alta Especialidad Ixtapaluca
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Contact:
- Álvaro Cabrera Garciá, MD
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-
Guanajuato
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León, Guanajuato, Mexico
- Hospital Regional de Alta Especialidad Bajío
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Contact:
- Lauro Fabián Amador Medina, MD
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Nuevo León
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Monterrey, Nuevo León, Mexico
- Hospital Universitario
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Contact:
- Andrés Gómez, MD
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Monterrey, Nuevo León, Mexico
- Imss Umae 25
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Contact:
- Diego Cruz Contreras, MD
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Tamaulipas
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Ciudad Victoria, Tamaulipas, Mexico
- Hospital Regional de Alta Especialidad Ciudad Victoria
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Contact:
- Ramón A Martínez Hernández, MD
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
11 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Mexican adults with newly diagnosed AML who are candidates for treatment (intensive or not intensive)
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
overall survival
Time Frame: 3 year
|
3 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
March 22, 2020
Primary Completion (Anticipated)
September 30, 2025
Study Completion (Anticipated)
October 31, 2025
Study Registration Dates
First Submitted
March 13, 2020
First Submitted That Met QC Criteria
March 13, 2020
First Posted (Actual)
March 17, 2020
Study Record Updates
Last Update Posted (Actual)
March 17, 2020
Last Update Submitted That Met QC Criteria
March 13, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HEM-3094-19-25-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.