NGS in AML Relapse (NGSAML)

Retrospective Study of AML Relapses Using Targeted NGS Analysis

Acute myeloid leukemia (AML) relapse is often associated with a clonal evolution at the cytogenetic and molecular level and therefore represents a challenge in the treatment of AML. Targeted sequencing is now usually done at diagnosis in AML, as only a small core group of genes is frequently mutated in AML and myelodysplastic syndromes. This approach, contrary to WGS is cheaper, together with a rapid turnaround and high sequencing coverage depths allowing the detection of variant allele fractions as low as 2%.

In the investigator's center, targeted analysis of AML patients is routinely realized at diagnosis and at relapse. In thses patients, five different clonal evolution patterns including cytogenetic and molecular analysis at relapse will be evaluated: (1) Stability, defined by no clonal change, (2) Gain, strictly defined by acquisition of additional variations (mutations or cytogenetic alterations), (3) Loss, strictly defined by loss of variants or regression, (4) Gain and Loss, indicating the combination of both Gain and Loss patterns, (5) Emergence, defined by the emergence of alterations that were unrelated to those found at diagnosis.

Karyotype and the mutations of up to 40 AML patients benefited from targeted NGS in the clinical hematology laboratory of the Hopitaux Universitaires de Strasbourg both at the time of the diagnosis of and the relapse will be studied, together with clinical and other biological characteristics.

Study Overview

• Status: Unknown
• Conditions: Acute Myeloid Leukemia

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

Study Locations

• France
  • Strasbourg, France, 67098
    • Recruiting
    • Laboratoire d'Hématologie
    • Contact: Laurent MAUVIEUX, MD, PhD; Phone Number: 33 3 88 12 75 27; Email: laurent.mauvieux@chru-strasbourg.fr
    • Principal Investigator: Laurent MAUVIEUX, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with AML that relapsed studied in the clinical laboratory of hematology of the Hopitaux Universitaires de Strasbourg, France

Description

• Inclusion criteria:

  • patients with AML that relapsed studied in the clinical laboratory of hematology of the Hopitaux Universitaires de Strasbourg, France
  • given consentment or non-opposition for retrospective anonymous analysis of clinical and data

• Exclusion criteria:

  • person under tutorship-
  • persons who asked to withdraw from the study

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
overall survival of the different clonal evolution patterns	6 months

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2018
• Primary Completion (Anticipated): June 1, 2019
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: June 27, 2018
• First Submitted That Met QC Criteria: July 9, 2018
• First Posted (Actual): July 10, 2018

Study Record Updates

• Last Update Posted (Actual): July 12, 2018
• Last Update Submitted That Met QC Criteria: July 10, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Acute myeloid leukemia; Relapse; Mutations
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Disease Attributes; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Recurrence
• Other Study ID Numbers: 7106

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No