Molecular Diagnostic Platform for AML
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|ClinicalTrials.gov Identifier: NCT04446741|
Recruitment Status : Recruiting
First Posted : June 25, 2020
Last Update Posted : September 5, 2021
|Condition or disease|
|Acute Myeloid Leukemia (AML)|
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|
|Estimated Enrollment :||2000 participants|
|Official Title:||Developing a Molecular Diagnostic Platform for Personalized Medicine for Acute Myeloid Leukemia|
|Actual Study Start Date :||October 1, 2019|
|Estimated Primary Completion Date :||October 2022|
|Estimated Study Completion Date :||October 2022|
Acute Myeloid Leukemia (AML)
Newly diagnosed or relapsed/resistant AML
- Frequency of FLT3, NPM1 and CEBPa mutations [ Time Frame: Baseline ]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.
- Frequency of mutations detected by Next Generation Sequency (NGS) [ Time Frame: Baseline ]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)
- Frequency of mutations detected by conventional PCR (FLT3, NPM1 and CEBPa) in every sample (diagnosis, relapse) [ Time Frame: Baseline ]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.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04446741
|Contact: Olga Garcia||+34 609 128 firstname.lastname@example.org|
|Hospital Universitario Reina Sofía||Recruiting|
|Contact: Joaquín Sánchez|
|Principal Investigator: Joaquín Sánchez|
|Hospital Universitario de Gran Canaria Dr. Negrín||Recruiting|
|Las Palmas De Gran Canaria, Spain|
|Contact: Maite Gómez Casares|
|Principal Investigator: Maite Gómez Casares|
|Hospital Doce de Octubre||Recruiting|
|Contact: Rosa Ayala|
|Principal Investigator: Rosa Ayala|
|Clínica Universidad de Navarra||Recruiting|
|Contact: María José Calasanz|
|Principal Investigator: María José Calasanz|
|Hospital Universitario de Salamanca||Recruiting|
|Contact: Carmen Chillon|
|Principal Investigator: Carmen Chillon|
|Hospital Universitario Virgen del Rocío||Recruiting|
|Contact: José Antonio Pérez Simón|
|Principal Investigator: José Antonio Pérez Simón|
|Hospital Universitario La Fe||Recruiting|
|Contact: Eva Barragan|
|Principal Investigator: Eva Barragán|
|Principal Investigator:||Pau Montesinos||Hospital Universitario La Fe|