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Trial Title:
Impact of Optical Genome Mapping in Acute Myeloblastic Leukemia
NCT ID:
NCT05499611
Condition:
Acute Myeloblastic Leukemia
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Conditions: Keywords:
Optical Genome Mapping (OGM)
Acute Myeloblastic Leukemia (AML)
Complex Karyotype
Prognosis
Study type:
Observational
Overall status:
Active, not recruiting
Study design:
Time perspective:
Retrospective
Summary:
A retrospective study using a new technology will be performed: the Optical Genome
Mapping (OGM) on acute myelogenous leukemia (AML) samples stored at the CRB-Cancer of the
Bordeaux University Hospital and annotated in the DATAML clinical database. The main
objective is to estimate the proportion of AML patients for whom OGM detects at least one
additional abnormality compared to conventional techniques. This study will constitute an
important step in the validation of COA as a reference technique for cytogenetic analysis
in AML, replacing the classical techniques, and could also constitute a first argument
for redesigning the prognostic classification of AML.
Detailed description:
In AML prognostic classifications, such as the ELN 2017 classification, which are used to
guide treatment choices in the majority of protocols, rely heavily on genetic
abnormalities. The Optical Genome Mapping (OGM) is a new technology that combines in one
and the same technique the results of karyotype, FISH and SNP-Array, the latter being
very little used in current practice in AML. OGM with greater sensitivity and a better
resolution than the usual techniques should therefore allow us to identify more
abnormalities than conventional cytogenetics; we would then like to determine whether
these additional abnormalities have a prognostic impact, i.e., whether they lead to
reclassification of patients initially classified as "favorable" or "intermediate" into
the "unfavorable" prognostic category, with therapeutic consequences.
A retrospective study using the OGM is will be performed on samples stored at the
CRB-Cancer of the Bordeaux University Hospital and annotated in the DATAML clinical
database. In an original way, the focus will be on AML patients in whom 1 to 3
chromosomal abnormalities (non-recurrent WHO, not related to an unfavourable prognosis)
have already been demonstrated by classical techniques, making the hypothesis that it is
in this population that we would more easily have patients who could fall into the
definition of the complex karyotype and thus into the unfavourable risk category.
OGM should therefore reveal a greater number of abnormalities which would allow a better
definition of karyotypes with abnormalities, the number of complex and/or monosomal
karyotypes and a better stratification of the prognosis of these patients with AML. This
is an applied translational research study based on innovative technology that will
define the place of OGM over current techniques used in the initial management of AML
patients, and it may well become the new standard for cytogenetic analysis of AML in the
coming years.
Criteria for eligibility:
Study pop:
Patients with diagnosis of AML (with a minimum follow-up of 24 months)
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
- Patients ≥ 18 years and ≤ 65 years of age who have been treated with intensive
chemotherapy
- Diagnosis of AML (with a minimum follow-up of 24 months)
- Presence of samples included in CRB-K in the AML collection
- Cytogenetic data available: karyotype with 1-3 abnormalities present in one or more
clones, excluding recurrent WHO abnormalities (t(8;21), inv(16) or t(16;16),
t(9;11), t(v;11)(v;q23. 3), t(6;9), inv(3) or t(3;3) and t(9;22)) or assigned by
itself to an unfavorable prognosis: -5 or del(5q); -7; -17/abn(17p).
- Molecular data available for the following genes: ASXL1, CEBPA, FLT3-ITD, NPM1,
RUNX1 and TP53 (the list of genes of interest may be adapted according to the
upcoming ELN 2022 classification)
Exclusion Criteria:
- Samples not included in the CRB-K (lack of consent, insufficient material...)
- Karyotype with one of the following abnormalities: (t(8;21), inv(16) or t(16;16),
t(9;11), t(v;11)(v;q23.3), t(6;9), inv(3) or t(3;3), and t(9;22)) or associated with
an unfavorable prognosis on its own: -5 or del(5q); -7; -17/abn(17p)
- Karyotype without clonal abnormality
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
CHU de Bordeaux, service Hématologie Biologique
Address:
City:
Bordeaux
Country:
France
Start date:
January 27, 2023
Completion date:
September 2024
Lead sponsor:
Agency:
University Hospital, Bordeaux
Agency class:
Other
Source:
University Hospital, Bordeaux
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05499611