NGS in AML Relapse

NCT ID: NCT03582241

Last Updated: 2018-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-27

Study Completion Date

2019-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Myeloid Leukemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Laboratoire d'Hématologie

Strasbourg, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Laurent MAUVIEUX, MD, PhD

Role: CONTACT

33 3 88 12 75 27

Facility Contacts

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Laurent MAUVIEUX, MD, PhD

Role: primary

33 3 88 12 75 27

Other Identifiers

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7106

Identifier Type: -

Identifier Source: org_study_id

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