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Clinical Trial Finder

Search Results

Clonal Architecture of ASXL1-mutated Myelofibrosis

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05710211
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University Hospital, Angers
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

POUILLART
Principal Investigator Affiliation University Hospital, Angers
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Myelofibrosis
Additional Details

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.

Arms & Interventions

Arms

Experimental: CLONEMF cohort

Interventions

Biological: - 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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

CHU Angers, Angers, France

Status

Address

CHU Angers

Angers, ,

Site Contact

Corentin ORVAIN, Dr

[email protected]

0033241355553

CHRU Brest, Brest, France

Status

Address

CHRU Brest

Brest, ,

Site Contact

Jean-Christophe IANOTTO, Pr

[email protected]

0033241355553

CH Cholet, Cholet, France

Status

Address

CH Cholet

Cholet, ,

Site Contact

Charles BESCOND, Dr

[email protected]

0033241355553

CHU Nantes, Nantes, France

Status

Address

CHU Nantes

Nantes, ,

Site Contact

Viviane DUBRUILLE, Dr

[email protected]

0033241355553

Hôpital Bicêtre, Paris, France

Status

Address

Hôpital Bicêtre

Paris, ,

Site Contact

Laurence Laurence, Dr

[email protected]

0033241355553

CH de Cornouaille, Quimper, France

Status

Address

CH de Cornouaille

Quimper, ,

Site Contact

Lenaïg LE CLECH, Dr

[email protected]

0033241355553

CHRU Tours - Hôpital Bretonneau, Tours, France

Status

Address

CHRU Tours - Hôpital Bretonneau

Tours, ,

Site Contact

Antoine MACHET, Dr

[email protected]

0033241355553

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