NCT05714592 Evaluation of Optical Genome Mapping in Phi Negative Myeloproliferative Neoplasia in the Detection of Acquired Cytogenetic Abnormalities
| NCT ID | NCT05714592 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire, Amiens |
| Condition | Myeloproliferative Neoplasm |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2023-05-17 |
| Primary Completion | 2027-05-18 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2023-05-17 with a primary completion date of 2027-05-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Standard cytogenetics (CBA +/- FISH) is of diagnostic and prognostic interest in Ph- MPN. However, its value is limited by the low frequency of detected abnormalities. The development of tools to increase the sensitivity of detection of chromosomal alterations is therefore particularly adapted to these pathologies. Optical genome mapping (OGM) is a high resolution "long read" technique that allows the identification of structural and copy number variations at the whole genome level. Several recent studies suggest that OGM is a future tool for cytogenetic characterization of haematological disorders. Its ability to describe structural abnormalities, including balanced ones, represents a major advantage over currently used technologies. Thus, OGM seems to be the key tool for cytogenetics of haematological malignancies in the coming years, making it possible to replace, under certain conditions, not only karyotype and FISH, but CMA and even RT-MLPA for the search for fusion transcripts, thus filling in the gaps in these techniques while maintaining their advantages. To define the place of this technology in Ph- MPN, the investigators will perform a OGM analysis on patients with Ph-MPN for whom bone marrow exploration is scheduled. These results will be compared with those of standard cytogenetics (CBA +/- FISH).
Eligibility Criteria
Inclusion Criteria: * Patient 18 years of age or older * Diagnosis or follow-up of polycythemia vera, essential thrombocythemia or primary or secondary myelofibrosis * Requires bone marrow cytogenetics at diagnosis or follow-up * Understanding of the French language * Information of the patient and collection of no objection * Person affiliated to a social security regime Exclusion Criteria: * Patient with BCR::ABL positive myeloproliferative neoplasia. * Person with a medical history that may impair the ability to understand the information notice
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05714592 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Myeloproliferative Neoplasm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05714592 currently recruiting?
Yes, NCT05714592 is actively recruiting participants. Contact the research team at Lestringant.valentin@chu-amiens.fr for enrollment information.
Where is the NCT05714592 trial being conducted?
This trial is being conducted at Amiens, France.
Who is sponsoring the NCT05714592 clinical trial?
NCT05714592 is sponsored by Centre Hospitalier Universitaire, Amiens. The trial plans to enroll 300 participants.