Molecular Diagnostic Platform for AML

September 3, 2021 updated by: PETHEMA Foundation

Developing a Molecular Diagnostic Platform for Personalized Medicine for Acute Myeloid Leukemia

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

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 (Anticipated)

2000

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

Study Locations

  • Spain
      • Córdoba, Spain
        • Recruiting
        • Hospital Universitario Reina Sofia
        • Contact:
          • Joaquín Sánchez
        • Principal Investigator:
          • Joaquín Sánchez
      • Las Palmas De Gran Canaria, Spain
        • Recruiting
        • Hospital Universitario de Gran Canaria Dr. Negrin
        • Contact:
          • Maite Gómez Casares
        • Principal Investigator:
          • Maite Gómez Casares
      • Madrid, Spain
        • Recruiting
        • Hospital Doce de Octubre
      • Pamplona, Spain
        • Recruiting
        • Clinica Universidad de Navarra
        • Contact:
          • María José Calasanz
        • Principal Investigator:
          • María José Calasanz
      • Salamanca, Spain
        • Recruiting
        • Hospital Universitario de Salamanca
        • Contact:
          • Carmen Chillon
        • Principal Investigator:
          • Carmen Chillon
      • Sevilla, Spain
        • Recruiting
        • Hospital Universitario Virgen del Rocio
        • Principal Investigator:
          • Jose Antonio Perez Simon
      • Valencia, Spain
        • Recruiting
        • Hospital Universitario la Fe
        • Contact:
          • Eva Barragan
        • Principal Investigator:
          • Eva Barragán

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

18 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients aged ≥18 years with a diagnosis of AML (new, relapse or refractory).

Description

Inclusion Criteria:

  • Have voluntarily given informed consent for the sending and processing of biological specimens, as well as for the analysis and reporting of the results on the mutation status of their AML.
  • Age greater than or equal to 18 years.
  • Morphological diagnosis of AML or acute leukemia of ambiguous lineage according to WHO criteria at diagnosis, relapse or resistance.

Exclusion Criteria:

  • Inability of the patient or his/her legal representative to understand and voluntarily sign the informed consent form

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

Cohorts and Interventions

Group / Cohort
Acute Myeloid Leukemia (AML)
Newly diagnosed or relapsed/resistant AML

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PETHEMA Foundation

Investigators

  • Principal Investigator: Pau Montesinos, Hospital Universitario la Fe

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (ACTUAL)

October 1, 2019

Primary Completion (ANTICIPATED)

October 1, 2022

Study Completion (ANTICIPATED)

October 1, 2022

Study Registration Dates

First Submitted

June 17, 2020

First Submitted That Met QC Criteria

June 23, 2020

First Posted (ACTUAL)

June 25, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 5, 2021

Last Update Submitted That Met QC Criteria

September 3, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PCR-LMA

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.

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