Clinical trial NCT03009708: Feasibility Study of Platelet Activation and Inflammatory Response of Platelets in Hematopoietic Stem Cell Allograft Patients Post-transplant: Spontaneously and After Stimulation by an CMV Antigen
Official title: Feasibility Study of Platelet Activation and Inflammatory Response of Platelets in Hematopoietic Stem Cell Allograft Patients Post-transplant: Spontaneously and After Stimulation by an CMV Antigen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Allograft
Keywords: Allograft
Cytomegalovirus
Platelets
Hematopoietic stem cells
Graft Versus Host Disease (GVH)
Hemostasis
Adaptive immunity
Innate immunity
Post graft follow up
Lead sponsor: Institut de Cancérologie de la Loire
Sponsor class: OTHER
Collaborators: name: Groupe sur l'Immunité des Muqueuses et Agents Pathogènes, (GIMAP)
name: Association Stéphanoise Pour la Recherche en Hématologie-Oncologie (ASPHRO)
First posted: 2017-01-04
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Traditionally known for their role in haemostasis, platelets have also an immune role.

Platelets play a key role in immune mediator secretion, and interact with innate and adaptive immune cells, contributing to the fight against pathogens, as viruses.

Cytomegalovirus (CMV) is responsible of allograft patients' serious infections, because of the induced immune depression. Platelets activation for patients is not determined during the post-graft period, and platelet induced inflammation following a CMV infection is not described.

Detailed description: The descriptive present study will determine if platelet activation is altered during the post-graft follow-up (day 30 to 90).

The activation will be studied spontaneously and after simulation by a CMV (Cytomegalovirus) antigen.

The study will also focus on inflammatory response variation, focusing on the cytokines release during the same post-graft follow-up (spontaneously and after CMV antigen stimulation).

This preliminary study could lead to a better understanding of the immune-modulator role of inflammation, controlled by the platelets, particularly in the initiation of the Graft-versus-host disease in this kind of population.

Eligibility criteria: Inclusion Criteria:

* Patients who received an allogeneic haematopoietic stem cell transplant for less than 2 months for any indication ;
* Platelets \> 20 G / L (Giga per Litre) for at least 7 days without transfusion support ;
* Patients affiliated to a social security scheme.

Exclusion Criteria:

* Patients receiving antiplatelet therapy ;
* Major protected or unable to give consent ;
* Pregnant women ;
* Vulnerable persons defined by French legislation.

Primary outcomes:
measure: In vitro spontaneous CD62P (P-selectin) expression level
timeFrame: 90 Days
measure: In vitro spontaneous CD63 (membrane protein) expression level
timeFrame: 90 Days
measure: In vitro CD62P (P-selectin) expression level after a CMV antigen stimulation
timeFrame: 90 Days
measure: In vitro CD63 (membrane protein) expression level after a CMV antigen stimulation
timeFrame: 90 Days
Secondary outcomes:
measure: Level of in vitro spontaneous platelet activation
timeFrame: 90 Days
measure: Level of in vitro platelet activation after a CMV antigen stimulation
timeFrame: 90 Days
Other outcomes:
Locations:
city: Saint-Priest en Jarez
country: France
facility: Institut de Cancérologie Lucien Neuwirth
Study officials:
affiliation: Institut de Cancérologie Lucien Neuwirth
name: CORNILLON Jérôme, PhD
role: PRINCIPAL_INVESTIGATOR
References: