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Trial Title:
Evaluation of Optical Genome Mapping in Phi Negative Myeloproliferative Neoplasia in the Detection of Acquired Cytogenetic Abnormalities
NCT ID:
NCT05714592
Condition:
Myeloproliferative Neoplasm
Optical Genome Mapping
Cytogenetics
Clonality
Prognostic Stratification
Conditions: Official terms:
Myeloproliferative Disorders
Chromosome Disorders
Chromosome Aberrations
Conditions: Keywords:
Myeloproliferative Neoplasm
Optical genome mapping
Cytogenetics
Clonality
Prognostic stratification
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Basic Science
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Blood sample
Description:
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
Arm group label:
Optical genome mapping
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).
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Centre Hospitalier Universitaire d'Amiens
Address:
City:
Amiens
Zip:
80000
Country:
France
Status:
Recruiting
Contact:
Last name:
Valentin Lestringant, MD
Phone:
03 22 08 70 23
Email:
Lestringant.valentin@chu-amiens.fr
Investigator:
Last name:
Hélène Guermouche Flament, MD
Email:
Principal Investigator
Investigator:
Last name:
Dominique Penther, MD
Email:
Principal Investigator
Start date:
January 27, 2023
Completion date:
January 2025
Lead sponsor:
Agency:
Centre Hospitalier Universitaire, Amiens
Agency class:
Other
Collaborator:
Agency:
Hôpital Jeanne de Flandre LIlle
Agency class:
Other
Collaborator:
Agency:
Centre Henri Becquerel
Agency class:
Other
Source:
Centre Hospitalier Universitaire, Amiens
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05714592
