Impact of Optical Genome Mapping in Acute Myeloblastic Leukemia

NCT05499611 | Completed

• 1 other identifier: CHUBX 2022/28
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Myeloblastic Leukemia

Keywords

Optical Genome Mapping (OGM); Acute Myeloblastic Leukemia (AML); Complex Karyotype; Prognosis

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with more abnormalities detected by OGM than by conventional cytogenetics

  At baseline

Secondary Outcomes (5)

• Average number of additional abnormalities detected by OGM compared to conventional techniques

  At baseline

• Proportion of patients reclassified as complex and/or monosomal karyotype according to current ELN definitions

  At baseline

• Proportion of patients for whom a change in therapeutic management could have been proposed

  From baseline to Month 36

• Comparison of overall survival and event-free survival curves of patients reclassified to the unfavorable group to those of the intermediate and unfavorable groups in a historical cohort

  From baseline to Month 36

• Interobserver reproducibility for interpretation of OGM results (Fleiss Kappa coefficient)

  At baseline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with diagnosis of AML (with a minimum follow-up of 24 months)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CHU de Bordeaux, service Hématologie Biologique

Bordeaux, France

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2022
• First Posted: August 12, 2022
• Study Start: January 27, 2023
• Primary Completion: April 30, 2024
• Study Completion: December 31, 2024
• Last Updated: July 30, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)