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Molecular Characterization of Acute Erythroid Leukemia (M6-AML) Using Targeted Next-generation Sequencing

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ClinicalTrials.gov Identifier: NCT02861651
Recruitment Status : Completed
First Posted : August 10, 2016
Last Update Posted : August 10, 2016
Sponsor:
Information provided by (Responsible Party):
Institut Paoli-Calmettes

Brief Summary:
Acute erythroid leukemia (AEL) is a morphologically distinct, infrequent (o5%) acute myeloid leukemia (AML) designed as M6 in the French- American-British (FAB) classification. The World Health Organization classification recognizes two subclasses, M6a, a leukemia with myeloid blast cells, and M6b, a very rare, purely erythroid AML. It may be difficult to distinguish between a myelodysplastic syndrome and AEL because of the erythroblastic proliferation, which is increased when dysplasia is present. No recurrent cytogenetic abnormality is specific of AEL and the prognosis is poor with a median survival of 17 months. A study of 14 genes in a series of 92 cases has shown that mutations are frequent in AEL and somewhat differ from the other AMLs by the lower and higher proportion of FLT3-ITD and TP53 mutations, respectively. Only three cases of AEL are reported in the TCGA database. To further characterize AEL, determine whether it constitutes a distinct class of AML and document the reasons for its poor prognosis, the investigators will search for molecular alterations in 40 M6a-AMLs using array comparative genomic hybridization (aCGH) and next-generation sequencing (NGS) of 106 genes known or suspected to have a role in myeloid malignancies or in erythrocyte differentiation.

Condition or disease Intervention/treatment
Acute Myeloid Leukemia Other: DNA sequencing

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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Retrospective
Study Start Date : March 2014
Actual Primary Completion Date : July 2015





Primary Outcome Measures :
  1. Molecular characterization of AML-6 by NGS and CGH array [ Time Frame: 1 year ]
    Molecular characterization using array comparative genomic hybridization (aCGH) and next-generation sequencing (NGS) of 106 genes known or suspected to have a role in myeloid malignancies or in erythrocyte differentiation.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with AML-6 treated at Institut Paoli-Calmettes
Criteria

Inclusion Criteria:

  • Age>18 year
  • Diagnosis of AML6
  • Written consent obtained

Exclusion Criteria:

  • No written consent
  • No frozen samples

Information from the National Library of Medicine

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): NCT02861651


Locations
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France
Institut Paoli-Calmettes
Marseille, Bouches-du Rhône, France, 13009
Sponsors and Collaborators
Institut Paoli-Calmettes
Investigators
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Principal Investigator: Véronique Gelsi-Boyer, MD Institut Paoli-Calmettes
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Responsible Party: Institut Paoli-Calmettes
ClinicalTrials.gov Identifier: NCT02861651    
Other Study ID Numbers: M6-AML-14-004
First Posted: August 10, 2016    Key Record Dates
Last Update Posted: August 10, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
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Leukemia
Neoplasms by Histologic Type
Neoplasms