Trials Sponsors Conditions Drugs Pricing

Conditions

Myelofibrosis

Outcome Measures

Primary Outcomes (1)

Identify subgroups of ASXL1-mutated myelofibrosis based on clonal architecture data
The clonal architecture is defined by the number of mutations (numerical), the order of acquisition of the mutations (categorial, pre/post/separated), the mutational branching (categorial, yes/no), the presence of distinct clones (categorial, yes/no) and the transition towards homozygosity of each clone (categorial, yes/no). All parameters of clonal architecture will be analyzed together using a multivariate classification (Factor Analysis for Mixed Data) followed by a clustering which allow us to identify homogeneous cluster of patients.
24 months

Secondary Outcomes (10)

Description of previously constituted prognostic genomic groups (according to Luque Paz et al. 2021) within identified clusters of clonal architecture
24 months
Studying the functional characteristics of each subtype of clonal architecture by transcriptomics
24 months
Comparison of male proportion within the subtypes of clonal architecture
24 months
Comparison of age at the time of diagnosis within the subtypes of clonal architecture
24 months
Comparison of blood counts within the subtypes of clonal architecture
24 months
+5 more secondary outcomes

Study Arms (1)

CLONEMF cohort

EXPERIMENTAL

Biological: Clonal architecture determination

Interventions

Clonal architecture determinationBiological

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

CLONEMF cohort

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Adults (age ≥18 years),
Affiliated to the national social security system,

Sponsors & Collaborators

University Hospital, Angers
Governmentlead

Study Sites (13)

CHU Angers

Angers, France

RECRUITING

Corentin ORVAIN, DrCONTACT

Corentin ORVAIN, DrPRINCIPAL INVESTIGATOR

CHRU Brest

Brest, France

NOT_YET_RECRUITING

Jean-Christophe IANOTTO, PrCONTACT

Jean-Christophe IANOTTO, PrPRINCIPAL INVESTIGATOR

CH Cholet

Cholet, France

MeSH Terms

Conditions

Primary Myelofibrosis

Condition Hierarchy (Ancestors)

Myeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

POUILLART
University Hospital, Angers
STUDY DIRECTOR

Central Study Contacts

Margaux Wiber, PharmD.

CONTACT

0033241355553 margaux.wiber@chu-angers.fr

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: OTHER
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER GOV
Responsible Party: SPONSOR

Study Record Dates

First Submitted

December 28, 2022

First Posted

February 2, 2023

Study Start

April 24, 2023

Actual (reported)

Primary Completion

April 23, 2027

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Clonal Architecture of ASXL1-mutated Myelofibrosis

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (10)

Study Arms (1)

CLONEMF cohort

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (13)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (10)

Study Arms (1)

CLONEMF cohort

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (13)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations