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 (FIPALLOC)

May 11, 2018 updated by: Institut de Cancérologie de la Loire

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Saint-Priest en Jarez, France, 42 270
        • Institut de Cancérologie Lucien Neuwirth

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In vitro spontaneous CD62P (P-selectin) expression level
Time Frame: 90 Days
In vitro spontaneous CD62P (P-selectin) expression level will be calculated, and will reflect platelet activation for Hematopoietic stem cells allograft patients during their follow up.
90 Days
In vitro spontaneous CD63 (membrane protein) expression level
Time Frame: 90 Days
In vitro spontaneous CD63 (membrane protein) expression level will be calculated, and will reflect platelet activation for Hematopoietic stem cells allograft patients during their follow up.
90 Days
In vitro CD62P (P-selectin) expression level after a CMV antigen stimulation
Time Frame: 90 Days
In vitro CD62P (P-selectin) expression level will be calculated after a CMV antigen stimulation, and will reflect platelet activation for Hematopoietic stem cells allograft patients during their follow up.
90 Days
In vitro CD63 (membrane protein) expression level after a CMV antigen stimulation
Time Frame: 90 Days
In vitro CD63 (membrane protein) expression level will be calculated after a CMV antigen stimulation, and will reflect platelet activation for Hematopoietic stem cells allograft patients during their follow up.
90 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of in vitro spontaneous platelet activation
Time Frame: 90 Days
Level of in vitro spontaneous platelet activation for Hematopoietic stem cells allograft patients during their follow up. The level is calculated with PF4 (Recombinant Platelet Factor 4), RANTES (Chemokine (C-C motif) ligand 5), soluble CD40L (CD 40 ligand), MIP1alpha (Macrophage Inflammatory Proteins), sCD62P (soluble p-selectin) spontaneous expression level.
90 Days
Level of in vitro platelet activation after a CMV antigen stimulation
Time Frame: 90 Days
Level of in vitro platelet activation after a CMV antigen stimulation for Hematopoietic stem cells allograft patients during their follow up. The level is calculated with PF4 (Recombinant Platelet Factor 4), RANTES (Chemokine (C-C motif) ligand 5), soluble CD40L (CD 40 ligand), MIP1alpha (Macrophage Inflammatory Proteins), sCD62P (soluble p-selectin) expression level.
90 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut de Cancérologie de la Loire

Collaborators

Groupe sur l'Immunité des Muqueuses et Agents Pathogènes, (GIMAP)
Association Stéphanoise Pour la Recherche en Hématologie-Oncologie (ASPHRO)

Investigators

  • Principal Investigator: CORNILLON Jérôme, PhD, Institut de Cancérologie Lucien Neuwirth

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 21, 2017

Primary Completion (Actual)

September 12, 2017

Study Completion (Actual)

November 6, 2017

Study Registration Dates

First Submitted

December 30, 2016

First Submitted That Met QC Criteria

December 30, 2016

First Posted (Estimate)

January 4, 2017

Study Record Updates

Last Update Posted (Actual)

May 14, 2018

Last Update Submitted That Met QC Criteria

May 11, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2016-1101
  • 2016-A01833-48 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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