NCT05499611Completed
Impact of Optical Genome Mapping in Acute Myeloblastic Leukemia
Contribution of Optical Genome Mapping to the Prognostic Classification of Acute Myeloblastic Leukemia Evaluation of the Clinical Utility of DNA Optical Mapping in the Management of Acute Myeloblastic Leukemia (COALA)
Source: ClinicalTrials.gov · Last updated 30 Jul 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 120 (actual)
- First submitted
- 10 Aug 2022
- Start date
- 27 Jan 2023
- Primary completion date
- 30 Apr 2024
- Lead sponsor
- University Hospital, Bordeaux
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT05499611
What you commit to
- Study type: Observational
- Participants enrolled: 120
- From 27 Jan 2023 to the primary completion date, 30 Apr 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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
Who the study is looking for
- 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)
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU de Bordeaux, service Hématologie Biologique Coordinator of this site? Confirm its status | Bordeaux | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.