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CompletedNCT03009708FIPALLOCUpdated May 14, 2018

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

An interventional study of Blood samples in Allograft, sponsored by Institut de Cancérologie de la Loire. Completed at 1 site in France. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-05-14.

Sponsored by Institut de Cancérologie de la Loire · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Allograft

Keywords

  • Allograft
  • Cytomegalovirus
  • Platelets
  • Hematopoietic stem cells
  • Graft Versus Host Disease (GVH)
  • Hemostasis
  • Adaptive immunity
  • Innate immunity
  • Post graft follow up
03

In context

Lead sponsor

Institut de Cancérologie de la Loire is the lead sponsor of 28 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Patients receiving antiplatelet therapy ;
  • Major protected or unable to give consent ;
  • Pregnant women ;
  • Vulnerable persons defined by French legislation.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • 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

Interventions

  • OtherBlood 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.

06

What researchers measure

Primary outcomes

  1. In vitro spontaneous CD62P (P-selectin) expression level

    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.

    Time frame: 90 Days

  2. In vitro spontaneous CD63 (membrane protein) expression level

    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.

    Time frame: 90 Days

  3. In vitro CD62P (P-selectin) expression level after a CMV antigen stimulation

    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.

    Time frame: 90 Days

  4. In vitro CD63 (membrane protein) expression level after a CMV antigen stimulation

    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.

    Time frame: 90 Days

Secondary outcomes

  1. Level of in vitro spontaneous platelet activation

    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.

    Time frame: 90 Days

  2. Level of in vitro platelet activation after a CMV antigen stimulation

    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.

    Time frame: 90 Days

07

Study locations

1 site
  • Institut de Cancérologie Lucien Neuwirth
    Saint-Priest en Jarez, 42 270, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 14, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03009708
Lead 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)
Responsible party
Sponsor
First posted
Jan 4, 2017
Start date
Mar 21, 2017
Primary completion
Sep 12, 2017
Completion
Nov 6, 2017
Last update
May 14, 2018

Study contacts

CORNILLON Jérôme, PhD
principal investigator · Institut de Cancérologie Lucien Neuwirth

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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