PreeclampsiaNCT00190177
ECLAXIR:Search for an Association Between CX3CR1 V249I Polymorphism, Preeclampsia and Endothelial Injury
An observational study of Preeclampsia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The study hypothesis is the involvement of the couple CX3CR1/CX3CL1 in occurrence of endothelial injury in preeclampsia. According to this hypothesis, Carriers of the I249 allele who express less CX3CR1 shoud be protected against this risk. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preeclampsia
- How many people
- 370 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2003to Oct 2007
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- cases: pregnant woman, evolutive pregnancy, preeclampsia, caucasian, consenting to the study
Who cannot join
- Cases:
- multiple pregnancy, proteinuria > 300 mg/24h before 21th gestation week.
Trial locations and contacts
1 site in 1 country.
About this study
The study hypothesis is the involvement of the couple CX3CR1/CX3CL1 in occurrence of endothelial injury in preeclampsia. According to this hypothesis, Carriers of the I249 allele who express less CX3CR1 shoud be protected against this risk. The main objective of the study is the search of an association between CX3CR1 V249I polymorphism and preeclampsia. The secondary aims are the search of an association with the most severe forms of preeclampsia and endothelial injury.
Read the detailed description
It is a case-control multicenter study 185 caucasian pregnant women with preeclampsia and 185 paired controls without preeclampsia will be included.
The frequency of the V249I polymorphism in african black population will be determined by studying 200 subjects (100 cases and 100 controls).
The V249I polymorphism will be identified by PCR followed by enzyme digestion. Endothelial injury will be identified using three assays : von Willebrand factor, soluble VCAM-1 and thrombomodulin plasma levels.
CX3CR1 involvement in preeclampsia would have potential diagnostic and therapeutic consequences.
- Conditions
- Preeclampsia
- Medical subject headings
- Pre-Eclampsia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startMar 2003
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Time perspective
- Retrospective
- Enrolment
- 370 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent Mandelbrot, MD-PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00190177
- Sponsor's protocol ID
- P020925
- Status last verified
- Sep 2005
- First submitted
- 12 Sep 2005
- Last updated
- 18 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ECLAXIR:Search for an Association Between CX3CR1 V249I Polymorphism, Preeclampsia and Endothelial Injury
- ClinicalTrials.gov ID
- NCT00190177
- Acronym / sponsor ID
- P020925
- Conditions
- Preeclampsia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 370 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Mar 2003
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 19 Sep 2005 (estimated)
- 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 hypothesis is the involvement of the couple CX3CR1/CX3CL1 in occurrence of endothelial injury in preeclampsia. According to this hypothesis, Carriers of the I249 allele who express less CX3CR1 shoud be protected against this risk. The main objective of the study is the search of an association between CX3CR1 V249I polymorphism and preeclampsia. The secondary aims are the search of an association with the most severe forms of preeclampsia and endothelial injury.
Detailed description
It is a case-control multicenter study 185 caucasian pregnant women with preeclampsia and 185 paired controls without preeclampsia will be included.
The frequency of the V249I polymorphism in african black population will be determined by studying 200 subjects (100 cases and 100 controls).
The V249I polymorphism will be identified by PCR followed by enzyme digestion. Endothelial injury will be identified using three assays : von Willebrand factor, soluble VCAM-1 and thrombomodulin plasma levels.
CX3CR1 involvement in preeclampsia would have potential diagnostic and therapeutic consequences.
Study design
- Time perspective
- Retrospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- cases: pregnant woman, evolutive pregnancy, preeclampsia, caucasian, consenting to the study
Key exclusion criteria (2 listed)
- Cases:
- multiple pregnancy, proteinuria > 300 mg/24h before 21th gestation week.
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
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2013.
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Severe Preeclampsia
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.
Laurent Mandelbrot, MD-PhD principal investigator
Assistance Publique - Hôpitaux de Paris
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 Preeclampsia, run by Assistance Publique - Hôpitaux de Paris 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 18 Oct 2013. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 18 Oct 2013.