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IL-33, Endocan and Endothelial Cells (IL_33)

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ClinicalTrials.gov Identifier: NCT03984383
Recruitment Status : Not yet recruiting
First Posted : June 13, 2019
Last Update Posted : June 13, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

Brief Summary:

The study aims to investigate the inflammatory response of endothelial cells to various stimulations, in particular the production of IL33 and of endocan in response to allergens, agonists of microorganisms and pollutants.

For that purpose, this project attempts to set up a biological collection of lung and umbilical cord endothelial cells.

Lung endothelial cells are resected from a surgical specimen, resulting from a lung cancer surgery.

Umbilical cord-derived endothelial cells are taken from the umbilical cord collected during the delivery.


Condition or disease
Endothelial Cell

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Study Type : Observational
Estimated Enrollment : 184 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Regulation of IL33, Endocan and Their Targets in Primary Human Endothelial Cells
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : September 1, 2020

Group/Cohort
Lung-derived endothelial cells
Every patient of more than 18 years undergoing lung cancer surgery in the department of thoracic surgery of the University Hospital of Lille.
Umbilical cord-derived endothelial cells
Every patient of more than 18 years giving birth in the University Hospital of Lille in the absence of significant materno-foetal disorder (for example: meconium-stained amniotic fluid, chorioamnionitis, placental thrombosis, eclampsia etc.) or of infection for HIV, VHB, VHC or if unknown status for HIV, VHB, VHC the day of the childbirth.



Primary Outcome Measures :
  1. change in the level of messenger RNA expressed as IL-33 / GAPDH ratio between stimulated and unstimulated primary human lung endothelial cells. [ Time Frame: change from Baseline at 48 hours after stimulation ]

Secondary Outcome Measures :
  1. change in the level of messenger RNA expressed as IL-33 / GAPDH ratio between stimulated and unstimulated primary human lung endothelial cells. [ Time Frame: change from Baseline at 4 hours, 12h ours, 24 hours after stimulation ]
  2. change in the level of messenger RNA expressed as IL-33 / GAPDH ratio between stimulated and unstimulated primary human umbilical cord-derived endothelial cells. [ Time Frame: change from Baseline at 4 hours, 12h ours, 24 hours and 48 hours after stimulation ]
  3. change in IL33 protein concentration between stimulated and unstimulated primary human lung endothelial cells. [ Time Frame: change from Baseline at 4 hours, 12h ours, 24 hours and 48 hours after stimulation ]
  4. change in IL33 protein concentration between stimulated and unstimulated primary human umbilical cord-derived endothelial cells. [ Time Frame: change from Baseline at 4 hours, 12h ours, 24 hours and 48 hours after stimulation ]
  5. change in the level of messenger RNA expressed as endocan / GAPDH ratio between stimulated and unstimulated primary human lung endothelial cells. [ Time Frame: change from Baseline at 4 hours, 12h ours, 24 hours and 48 hours after stimulation ]
  6. change in the level of messenger RNA expressed as endocan / GAPDH ratio between stimulated and unstimulated primary human umbilical cord-derived endothelial cells. [ Time Frame: change from Baseline at 4 hours, 12h ours, 24 hours and 48 hours after stimulation ]
  7. change in endocan protein concentration between stimulated and unstimulated primary human lung endothelial cells. [ Time Frame: change from Baseline at 4 hours, 12h ours, 24 hours and 48 hours after stimulation ]
  8. change in endocan protein concentration between stimulated and unstimulated primary human umbilical cord-derived endothelial cells. [ Time Frame: change from Baseline at 4 hours, 12h ours, 24 hours and 48 hours after stimulation ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Lung-derived endothelial cells : every patient of more than 18 years undergoing lung cancer surgery in the department of thoracic surgery of the University Hospital of Lille.

Umbilical cord-derived endothelial cells : every patient of more than 18 years giving birth in the University Hospital of Lille in the absence of significant materno-foetal disorder (for example: meconium-stained amniotic fluid, chorioamniotis, placental thrombosis, eclampsia etc.) or of infection for HIV, VHB, VHC or if unknown status for HIV, VHB, VHC the day of the childbirth.

Criteria

Inclusion Criteria:

  • Age > 18 years
  • signed consent
  • Pregnant woman for umbilical cord-derive-endothelial cells

Exclusion Criteria:

  • Age < 18 years
  • Refusal to participate to the study
  • Endothelial cord-drived endothelial cells :

    • significant materno-foetal disorder (for example: meconium-stained amniotic fluid, chorioamnionitis, placental thrombosis, eclampsia etc.)
    • infection for HIV, VHB, VHC
    • unknown status for HIV, VHB, VHC the day of the childbirth.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03984383


Contacts
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Contact: Cécile Chenivesse, MD, Ph 03 20 44 59 48 ext +33 cecile.chenivesse@chru-lille.fr

Locations
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France
CHU Lille Not yet recruiting
Lille, France, 59000
Contact: Cécile Chenivesse, MD, Ph    03 20 44 59 48 ext +33    cecile.chenivesse@chru-lille.fr   
Contact: Corine Glineur, Ph    03 20 87 71 83 ext +33    corine.glineur@pasteur-lille.fr   
Principal Investigator: Cécile Chenivesse, MD,Ph         
Sponsors and Collaborators
University Hospital, Lille
Investigators
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Principal Investigator: Cécile Chenivesse CHU Lille, Service de Pneumologie et Immuno-Allergologie

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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03984383     History of Changes
Other Study ID Numbers: 2017_13
2018-A03087-48 ( Other Identifier: ID-RCB number, ANSM )
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Lille:
Endothelial cells
inflammation
endothelial dysfunction
IL-33
Endocan