Megakaryocyte Heterogeneity in Sickle Cell Disease

NCT06850337 | Not Yet Recruiting

• 2 other identifiers: PAP_RIPH2_2024/042024-A01093-44
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Sickle cell disease (SCD) is characterized by chronic hemolytic anemia, painful crisis called vaso-occlusive crisis (VOC) and chronic inflammation. Activated platelets of SCD patients participated to both chronic inflammation and painful VOC. Platelets are anucleated cells from the fragmentation of megakaryocytes in bone marrow. The main aim of this study is to characterize the distribution of the different megakaryocyte subpopulations of sickle cell disease patients SS and SC and in particular the "immune" megakaryocytes CD148+CD48+ and to compare it with the platelet phenotype.

Conditions

Sickle Cell Disease (SCD)

Keywords

sickle cell disease; immune megakaryocytes; platelets; CD48; CD148

Outcome Measures

Primary Outcomes (1)

• proportion of immune megakaryocytes CD148+CD48+ in bone marrow

  The primary outcome will be the evaluation of the proportion of immune megakaryocytes CD148+CD48+ in bone marrow of sickle cell disease patients in comparison to control group.

  24 months

Secondary Outcomes (1)

• platelet phenotype

  24 months

Study Arms (3)

SS patients

patients with SS sickle cell disease

SC patients

patients with SC sickle cell disease

control group AA

patient without sickle cell disease (AA hemoglobin)

Eligibility Criteria

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

Study Population

Patients with sockle celle disease are patients who come for their disease. Control group are patients who come at the University hospital of Guadeloupe (Pointe à Pitre), for hip or knee replacement and will do not suffer from chronic disease.

You may qualify if:

• patients with SS or SC SCD
• diagnosis of SCD performed by electrophoresis or HPLC in a reference laboratory for hemoglobinopathies
• patient followed up for SCD at the sickle cell center of Guadeloupe (University hospital of Guadeloupe, Pointe à Pitre)
• patients who will provide written informed consent in accordance with the Declaration of Helsinki
• patients affiliated to national social security
• the control group (AA subjects) will be patients older than 18 years old who come at the University hospital of Guadeloupe, (Pointe à Pitre) for hip or knee replacement and will do not suffer from chronic disease.

You may not qualify if:

• patients younger than 18 years old
• patients with hemoglobinopathy other than SS and SC SCD
• patients with a transfusion therapy or on bleeding therapy for less than three months
• patients no affiliated to national social security
• pregnant or breastfeeding patients

Sponsors & Collaborators

• Centre Hospitalier Universitaire de la Guadeloupe: lead

Study Sites (1)

Chu de La Guadeloupe

Pointe-à-Pitre, 97159, Guadeloupe

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

A specific research sample corresponding to a 5 ml tube of blood and a 5 ml tube of bone marrow (only for orthopedic surgery patients) will be taken during the inclusion visit for sickle cell patients. For patients without sickle cell , after verification of the eligibility criteria and collection of their agreement to participate, a 5 ml blood tube will be taken with determination of their AA genotype (on hemoglobin electrophoresis). As well as the collection of a 5 ml blood tube and a 5 ml bone marrow tube will be taken following the surgical procedure. Once the AA genetic status is confirmed, the bone marrow sample will be processed. Otherwise, the sample will be destroyed and the patient will not be included in the study.

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Veronique Baccini, MD PhD

  CHU de la Guadeloupe

  STUDY CHAIR

Central Study Contacts

Valérie Hamony Soter

CONTACT

+590590934677; valerie.soter@chu-guadeloupe.fr

Mélanie Petapermal

CONTACT

+590590934667; melanie.petapermal@chu-guadeloupe.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: February 27, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

GU (1)