NGS in AML Relapse (NGSAML)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT03582241

Recruitment Status : Unknown

Verified June 2018 by University Hospital, Strasbourg, France.
Recruitment status was: Recruiting

First Posted : July 10, 2018

Last Update Posted : July 12, 2018

Sponsor:

Information provided by (Responsible Party):

University Hospital, Strasbourg, France

Study Description

Brief Summary:

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.

Condition or disease
Acute Myeloid Leukemia

Study Design

Layout table for study information

Study Type :	Observational
Estimated Enrollment :	40 participants
Observational Model:	Cohort
Time Perspective:	Retrospective
Official Title:	Retrospective Study of AML Relapses Using Targeted NGS Analysis
Actual Study Start Date :	June 27, 2018
Estimated Primary Completion Date :	June 2019
Estimated Study Completion Date :	June 2019

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Familial acute myeloid leukemia with mutated CEBPA Cytogenetically normal acute myeloid leukemia Core binding factor acute myeloid leukemia

MedlinePlus related topics: Acute Myeloid Leukemia Leukemia

Genetic and Rare Diseases Information Center resources: Myeloid Leukemia Acute Myeloid Leukemia Acute Non Lymphoblastic Leukemia

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

overall survival of the different clonal evolution patterns [ Time Frame: 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes 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

Criteria

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

Contacts and Locations

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): NCT03582241

Contacts

Layout table for location contacts

Contact: Laurent MAUVIEUX, MD, PhD	33 3 88 12 75 27	laurent.mauvieux@chru-strasbourg.fr

Locations

Layout table for location information

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

Sponsors and Collaborators

University Hospital, Strasbourg, France

More Information

Layout table for additonal information

Responsible Party:	University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:	NCT03582241
Other Study ID Numbers:	7106
First Posted:	July 10, 2018 Key Record Dates
Last Update Posted:	July 12, 2018
Last Verified:	June 2018

Layout table for additional information

Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by University Hospital, Strasbourg, France:


Acute myeloid leukemia Relapse Mutations

Additional relevant MeSH terms:

Layout table for MeSH terms

Leukemia, Myeloid Leukemia, Myeloid, Acute Recurrence Leukemia	Neoplasms by Histologic Type Neoplasms Disease Attributes Pathologic Processes

To Top