Biocollection in MyeloDysplastic Syndrome (P-MDS)

NCT04869683 | Recruiting

• 1 other identifier: 29BRC20.0228
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Myelodysplastic syndromes (MDS) are chronic myeloid hemopathies characterized by ineffective hematopoiesis (with peripheral cytopenias) and which contrast with a marrow of normal richness. MDS is considered one of the four most common blood diseases. The incidence is estimated at 4,059 cases / year in 2012 with an average age of 78 years in men and 81 years in women (INCA report, Cancers in France in 2015). The incidence increases with lengthening of the lifespan. The main risk of MDS is transformation to acute leukemia in 30 to 40% of cases. Treatment options depend on clinical, hematologic and chromosomal abnormalities. The prognosis is considered to be at low or high risk of developing acute leukemia. This distinction will therefore have an impact on the therapeutic solution (s). MDS exhibit clinical, morphological and genetic heterogeneity. It is therefore necessary to form subgroups of patients to better understand the physiopathogenesis of this pathology. The constitution of a biocollection will make it possible to search for clinical and biological prognostic markers in order to identify patients progressing to acute myeloid leukemia.

Conditions

Myelodysplastic Syndromes; Myelodysplastic Anemia; Myelodysplastic Syndrome With Isolated Del(5Q); Myelodysplastic Syndrome With Ring Sideroblasts; Acute Myeloid Leukemia With Multilineage Dysplasia; Chromosome Abnormality

Keywords

MDS; 5q deletion; ring sideroblasts; AML

Outcome Measures

Primary Outcomes (1)

• Cohort MDS: epidemiologic MSD study

  MDS study in collecting data

  five years

Study Arms (1)

MDS follow up

OTHER

it is a description MDS patients study

Other: description of MDS pzatient cohort

Interventions

description of MDS pzatient cohort OTHER

description of MDS patient cohort

MDS follow up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Major
• patient with or suspected of myelodysplastic syndrome (WHO definition) at diagnosis and/or during follow-up, which is managed at the level of the Cancer-Hematology Institute of the Brest CHRU
• Presence of biological material collected within the CRB
• Patient's consent obtained

You may not qualify if:

• Minor and pregnant woman
• Lack of biological material collected within the CRB
• Refusal to participate: lack of consent - Unable to consent
• Patient under judicial protection: guardianship, curatorship ...

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

Chu Brest

Brest, 29609, France

RECRUITING

MeSH Terms

Conditions

Myelodysplastic Syndromes; Chromosome 5q Deletion Syndrome; Chromosome Aberrations

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nathalie Douet-Guilbert, MD,PhD

  CHRU Brest

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nathalie Douet-Guilbert, MD, PhD

CONTACT

+33229020215; nathalie.douet-guilbert@chu-brest.fr

Marie-Bérengère Troadec, PhD

CONTACT

+33229020215; marie-berenger.troadec@chu-brest.fr

Study Design

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

Model Details: Health services research and follow up DMS

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: May 3, 2021
• Study Start: October 19, 2022
• Primary Completion (Estimated): October 19, 2032
• Study Completion (Estimated): October 19, 2032
• Last Updated: February 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
• Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement

Locations

FR (1)