NCT03009708

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 30, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 4, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

March 21, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 6, 2017

Completed
Last Updated

May 14, 2018

Status Verified

May 1, 2018

Enrollment Period

6 months

First QC Date

December 30, 2016

Last Update Submit

May 11, 2018

Conditions

Allograft

Keywords

AllograftCytomegalovirusPlateletsHematopoietic stem cellsGraft Versus Host Disease (GVH)HemostasisAdaptive immunityInnate immunityPost graft follow up

Outcome Measures

Primary Outcomes (4)

  • 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.

    90 Days

  • 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.

    90 Days

  • 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.

    90 Days

  • 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.

    90 Days

Secondary Outcomes (2)

  • Level of in vitro spontaneous platelet activation

    90 Days

  • Level of in vitro platelet activation after a CMV antigen stimulation

    90 Days

Study Arms (1)

Allograft patients

EXPERIMENTAL

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

Blood samplesOTHER

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.

Allograft patients

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut de Cancérologie Lucien Neuwirth

Saint-Priest-en-Jarez, 42 270, France

Location

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • CORNILLON Jérôme, PhD

    Institut de Cancérologie Lucien Neuwirth

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2016

First Posted

January 4, 2017

Study Start

March 21, 2017

Primary Completion

September 12, 2017

Study Completion

November 6, 2017

Last Updated

May 14, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)