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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

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