Evaluation of Optical Genome Mapping in Phi Negative Myeloproliferative Neoplasia in the Detection of Acquired Cytogenetic Abnormalities

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire, Amiens

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patient with BCR::ABL positive myeloproliferative neoplasia.

Person with a medical history that may impair the ability to understand the information notice

Trial design

Design model

Single group

Treatments tested in this trial

  • Blood sample

    Other intervention

    The referring haematologist will suggest that the patient participate in the study during the consultation. In these patients, the investigators will perform OGM on the cytogenetic sample

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: Optical genome mappingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of patients with the same abnormalises detected with both OGM and standard cytogenetics

Number of patients for whom the OGM finds at least the abnormalises detected by standard cytogenetics.

Time frame
one year

Secondary outcomes

Other outcomes

Sponsors and contacts

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Centre Hospitalier Universitaire, Amiens

Lead sponsor

Hôpital Jeanne de Flandre LIlle

Collaborator

Centre Henri Becquerel

Collaborator