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Diagnostic Platform to Perform Centralized and Standardized Rapid Molecular Diagnosis by Next Generation Sequencing (NGS) in Patients Diagnosed With Acute Myeloid Leukemia.

NCT03311815 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 900

Last updated 2021-02-16

No results posted yet for this study

Summary

NGS studies will be done in stem cell leukemic population. The analysis of the samples to the diagnosis will be carried out using the 26 consensus genes: ASXL1 had, CBL, CEBPA, DNMT3A, EZH2, FLT3, GATA2, IDH1, IDH2, JAK2, KIT, KRAS, MPL, MLL, NPM1, NRAS, PTPN11, RUNX1, SETBP1, SF3B1, SRSF2, TET2, TP53, U2AF1, WT1. Regarding the 26 genes panel, it would have the advantage that the quantification of DNA from each sample will be carried out by fluorimetry using the AmpliSeq or TruSeq on Ion platforms torrent Proton or MySeq are handled in different laboratories.

Using NGS techniques the investigator will detect the recurrently mutated genes in AML to establish the biological role of each mutation.

The molecular characterization of the 700 samples which are estimated to pick up during the project will consist of massive sequencing of genes recurrently mutated in AML (ASXL1, had, CBL, CEBPA, DNMT3A, EZH2, FLT3, GATA2, IDH1, IDH2, JAK2, KIT, KRAS, MPL, MLL, NPM1, NRAS, PTPN11, RUNX1, SETBP1, SF3B1, SRSF2, TET2, TP53, U2AF1, WT1). Found mutations will be collated in the different databases of somatic variations to establish which of them could be classified as a driver or passenger.

Conditions

Interventions

DIAGNOSTIC_TEST

NGS techniques

Using NGS techniques we will detect the recurrently mutated genes in AML to establish the biological role of each mutation

Sponsors & Collaborators

  • PETHEMA Foundation

    lead OTHER

Principal Investigators

  • Pau Montesinos, Dr · PETHEMA Foundation

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-06
Primary Completion
2019-10-15
Completion
2019-10-15

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03311815 on ClinicalTrials.gov