This will be a translational study without any therapeutic intervention, for the purpose of analyzing the diagnostic and molecular results / characterization of adult patients with AML, regardless of the treatment they receive. Newly diagnosed or relapsed/resistant AML patients will be included.
This will be a multicenter, translational study without any therapeutic intervention. It will be conducted at 7 central laboratories (Hospital Universitari i Politècnic La Fe, Hospital Universitario de Salamanca, Hospital 12 de Octubre, Hospital Universitario Virgen del Rocío, Hospital Dr. Negrín de Las Palmas de Gran Canaria, Hospital Reina Sofía de Córdoba and Clínica Universidad de Navarra) belonging to the Spanish PETHEMA Group. The laboratories will receive and process bone marrow and peripheral blood samples of patients with AML at the time of the initial diagnosis or at relapse or resistance (first or subsequent relapse/resistance). The demographic data and clinical characteristics of the patients and of the AML, morphological and molecular response will be collected in case report forms (CRFs). Since the aim of this study is the molecular diagnosis of AML, all patients with AML will be included, regardless of the treatment (or no treatment at all) they receive. The physicians will receive the report about the molecular diagnosis for FLT3, NPM1, CBF and PML/RARa quickly (\<48-96 hours), in order to provide them with knowledge of the mutational status, that may cause changes to be made during the initial management of the disease. The aim of this project is to set up this rapid screening and diagnostic platform for AML by having specimens sent to 7 centralized reference laboratories across the country, where the molecular characteristics of leukemic cells will be analyzed by qRT-PCR and NGS technologies with high quality standards. This platform will provide homogeneous criteria for assessing the biological characteristics of the different entities that make up the disease. It is expected that samples of marrow and/or blood of 700 patients with AML will be analyzed per year.
Study Type
OBSERVATIONAL
Enrollment
2,000
Hospital Universitario Reina Sofía
Córdoba, Spain
RECRUITINGHospital Universitario de Gran Canaria Dr. Negrín
Las Palmas de Gran Canaria, Spain
RECRUITINGHospital Doce de Octubre
Madrid, Spain
Frequency of FLT3, NPM1 and CEBPa mutations
Frequency of each of the standard screening panel molecular alterations studied in the AML patients (FLT3, NPM1 and CEBPa), both in newly diagnosed and relapsed/resistant disease.
Time frame: Baseline
Frequency of mutations detected by Next Generation Sequency (NGS)
Frequency of mutations detected by NGS PCR (23 genes: FLT3, NPM1, DNMT3A, IDH2, IDH1, TET2, RUNX1, TP53, NRAS, WT1, PTPN11, KIT, U2AF1, KRAS, SMC1A, SMC3, PHF6, STAG2, RAD21, FAM5C, EZH2 and HNRNPK; if new genes are described,the panel can be extended) in every sample (diagnosis, relapse)
Time frame: Baseline
Frequency of mutations detected by conventional PCR (FLT3, NPM1 and CEBPa) in every sample (diagnosis, relapse)
Frequency of each of the standard screening panel molecular alterations studied by the conventional PCR in the AML patients (FLT3, NPM1 and CEBPa), both in newly diagnosed and relapsed/resistant disease.
Time frame: Baseline
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Clínica Universidad de Navarra
Pamplona, Spain
RECRUITINGHospital Universitario de Salamanca
Salamanca, Spain
RECRUITINGHospital Universitario Virgen del Rocío
Seville, Spain
RECRUITINGHospital Universitario La Fe
Valencia, Spain
RECRUITING