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

NCT ID: NCT03009708

Last Updated: 2018-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-21

Study Completion Date

2017-11-06

Brief Summary

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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

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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.

Conditions

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Allograft

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Allograft patients

Allograft patients followed at the Institut de Cancérologie Lucien Neuwirth perform blood samples during their post graft follow up in the usual practice, weekly. With the present study, two more blood tubes will be collected with the weekly blood samples.

Group Type EXPERIMENTAL

Blood samples

Intervention Type OTHER

Two blood tubes will be collected each week during 8 weeks maximum for the present study. Samples will start at day 30 post-graft and finish at day 90 post-graft maximum.

Interventions

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Blood samples

Two blood tubes will be collected each week during 8 weeks maximum for the present study. Samples will start at day 30 post-graft and finish at day 90 post-graft maximum.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Groupe sur l'Immunité des Muqueuses et Agents Pathogènes, (GIMAP)

UNKNOWN

Sponsor Role collaborator

Association Stéphanoise Pour la Recherche en Hématologie-Oncologie (ASPHRO)

UNKNOWN

Sponsor Role collaborator

Institut de Cancérologie de la Loire

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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CORNILLON Jérôme, PhD

Role: PRINCIPAL_INVESTIGATOR

Institut de Cancérologie Lucien Neuwirth

Locations

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Institut de Cancérologie Lucien Neuwirth

Saint-Priest-en-Jarez, , France

Site Status

Countries

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France

Other Identifiers

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2016-A01833-48

Identifier Type: OTHER

Identifier Source: secondary_id

2016-1101

Identifier Type: -

Identifier Source: org_study_id

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