Clonal Architecture of ASXL1-mutated Myelofibrosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-24

Study Completion Date

2031-04-30

Brief Summary

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Prospective study to decipher the clonal architecture of ASXL1-mutated primary and secondary myelofibrosis and its impact on prognosis

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Detailed Description

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The clonal architecture of myelofibrosis patients is still little described. Inconsistent results in terms of the prognostic value of some mutations are observed in the literature, in particular concerning ASXL1 mutations. We assume that a better understanding of the clonal architecture of ASXL1-mutated myelofibrosis could help refining the prognostic impact of ASXL1 mutations.

This study aims to evaluate a multicenter cohort of 50 patients. Blood of patients will be collected within 18 months of diagnosis. After 4 years of follow-up of the patient as part of his usual care, data on survival and leukemic transformation will be collected.

Conditions

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Myelofibrosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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CLONEMF cohort

Group Type EXPERIMENTAL

Clonal architecture determination

Intervention Type BIOLOGICAL

Biological:

* Determination of clonal architecture by sorting of circulating CD34 positive cells followed by cell culture and colony genotyping and/or single-cell DNA-sequencing
* Secondary outcome: transcriptomic study by RNA-sequencing

Interventions

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Clonal architecture determination

Biological:

* Determination of clonal architecture by sorting of circulating CD34 positive cells followed by cell culture and colony genotyping and/or single-cell DNA-sequencing
* Secondary outcome: transcriptomic study by RNA-sequencing

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Adults (age ≥18 years),
* Affiliated to the national social security system,
* ASXL1 mutated primary or secondary myelofibrosis,
* Signed the consent to participate in the study,
* Included, or consenting to be included, in the national clinical-biological database of France Intergroupe Syndrome Myéloprolifératifs (FIM).

Exclusion Criteria

* Patient with another active hematological disease or cancer at the time of diagnosis,
* Person subject to legal protection scheme or incapable of giving consent.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No