Endothelial CellIL-33NCT03984383
IL-33, Endocan and Endothelial Cells
An observational study of Endothelial Cell, run by University Hospital, Lille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endothelial Cell
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 8 Nov 2021to 8 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age > 18 years
- signed consent
- Pregnant woman for umbilical cord-derive-endothelial cells
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Regulation of IL33, Endocan and Their Targets in Primary Human Endothelial Cells
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.
- Conditions
- Endothelial Cell
- Keywords
- Endothelial cells, inflammation, endothelial dysfunction, IL-33, Endocan
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in the level of messenger RNA expressed as IL-33 / GAPDH ratio between stimulated and unstimulated primary human lung endothelial cells.
Measured: change from Baseline at 48 hours after stimulation
Secondary outcomes (8)
change in the level of messenger RNA expressed as IL-33 / GAPDH ratio between stimulated and unstimulated primary human lung endothelial cells.
Measured: change from Baseline at 4 hours, 12h ours, 24 hours after stimulation
change in the level of messenger RNA expressed as IL-33 / GAPDH ratio between stimulated and unstimulated primary human umbilical cord-derived endothelial cells.
Measured: change from Baseline at 4 hours, 12h ours, 24 hours and 48 hours after stimulation
change in IL33 protein concentration between stimulated and unstimulated primary human lung endothelial cells.
Measured: change from Baseline at 4 hours, 12h ours, 24 hours and 48 hours after stimulation
change in IL33 protein concentration between stimulated and unstimulated primary human umbilical cord-derived endothelial cells.
Measured: change from Baseline at 4 hours, 12h ours, 24 hours and 48 hours after stimulation
change in the level of messenger RNA expressed as endocan / GAPDH ratio between stimulated and unstimulated primary human lung endothelial cells.
Measured: change from Baseline at 4 hours, 12h ours, 24 hours and 48 hours after stimulation
change in the level of messenger RNA expressed as endocan / GAPDH ratio between stimulated and unstimulated primary human umbilical cord-derived endothelial cells.
Measured: change from Baseline at 4 hours, 12h ours, 24 hours and 48 hours after stimulation
change in endocan protein concentration between stimulated and unstimulated primary human lung endothelial cells.
Measured: change from Baseline at 4 hours, 12h ours, 24 hours and 48 hours after stimulation
change in endocan protein concentration between stimulated and unstimulated primary human umbilical cord-derived endothelial cells.
Measured: change from Baseline at 4 hours, 12h ours, 24 hours and 48 hours after stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2019
- Study start8 Nov 2021
- Primary completion8 Nov 2021
- Study completion8 Nov 2021
Why it stopped: No extension of ethic comitee
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endothelial CellStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cécile Chenivesse, Principal investigator, CHU Lille, Service de Pneumologie et Immuno-Allergologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03984383
- Sponsor's protocol ID
- 2017_13
- Other IDs
- 2018-A03087-48
- Acronym
- IL-33
- Status last verified
- Nov 2022
- First submitted
- 27 May 2019
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regulation of IL33, Endocan and Their Targets in Primary Human Endothelial Cells
- ClinicalTrials.gov ID
- NCT03984383
- Acronym / sponsor ID
- IL-33 / 2017_13
- Conditions
- Endothelial Cell
- Keywords
- Endothelial cells, inflammation, endothelial dysfunction, IL-33, Endocan
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No extension of ethic comitee
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 8 Nov 2021 (actual)
- Primary completion
- 8 Nov 2021 (actual)
- Study completion
- 8 Nov 2021 (actual)
- First posted
- 13 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Age > 18 years
- signed consent
- Pregnant woman for umbilical cord-derive-endothelial cells
Key exclusion criteria (6 listed)
- Age < 18 years
- Refusal to participate to the study
- Endothelial cord-drived endothelial cells :
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
8 secondary outcomes
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
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
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
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
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
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
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
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cécile Chenivesse principal investigator
CHU Lille, Service de Pneumologie et Immuno-Allergologie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endothelial Cell, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2022.