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IL-33, Endocan and Endothelial Cells

Sponsor
University Hospital, Lille (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT03984383
Collaborator
(none)
184
Enrollment
1
Location
72
Anticipated Duration (Months)
2.6
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    184 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Regulation of IL33, Endocan and Their Targets in Primary Human Endothelial Cells
    Anticipated Study Start Date :
    Jan 1, 2021
    Anticipated Primary Completion Date :
    Jan 1, 2027
    Anticipated Study Completion Date :
    Jan 1, 2027

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    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. [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. [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. [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. [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. [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. [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. [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. [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. [change from Baseline at 4 hours, 12h ours, 24 hours and 48 hours after stimulation]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hop Calmette Chu Lille Lille France 59000

    Sponsors and Collaborators

    • University Hospital, Lille

    Investigators

    • Principal Investigator: Cécile Chenivesse, CHU Lille, Service de Pneumologie et Immuno-Allergologie

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Lille
    ClinicalTrials.gov Identifier:
    NCT03984383
    Other Study ID Numbers:
    • 2017_13
    • 2018-A03087-48
    First Posted:
    Jun 13, 2019
    Last Update Posted:
    Nov 18, 2020
    Last Verified:
    Nov 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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

    Study Results

    No Results Posted as of Nov 18, 2020