Chronic HistiocytosisIHCNCT02668120
Search Elevated Serum Alkaline Phosphatase as a Marker of Prenatal Intervillositis Chronic Histiocytic
An observational study of Chronic Histiocytosis, run by University Hospital, Lille at 1 site in France.
Trial summary
Background : Chronic histiocytic intervillositis is a rare placental disease linked with poor perinatal outcome. In a recent study, a major antenatal increased alkaline phosphatase was suspected in patients affected by chronic histiocytic intervillositis. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Chronic Histiocytosis
- How many people
- 54 participants
- Where
- 1 siteFrance
- Study dates
- 16 Apr 2016to 11 Apr 2017
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patient pregnant following at the Lille University Hospital. The case group will be composed of patients who experienced chronic histiocytic intervillositis. Two control groups will be prospectively: The first will include patients whose pregnancy is low risk. The second will consist of pathological pregnancies (IUGR, Preeclampsia and Death In Utero).
Who may be able to join
- Patient aged 18 years or more
- Having signed a free and informed consent
- Enjoying a social security scheme
- Patient who gave birth at the Lille University Hospital between 2000 and 2009.
- Lesion of intervillositis chronic histiocytic (IHC) diagnosed during histological examination of the placenta.
- An alkaline phosphatase assay during pregnancy is available and has been achieved at University Hospital of Lille.
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- Prior information and not opposition of the patient to the secondary use of data collected in medical file.
- No pathological obstetric history, no current pregnancy complications
- Followed antenatal clinics at the Lille University Hospital
- A gestational age corresponding to one of the cases (pairing ± 1 week)
- No chronic intervillositis after pathological examination of the placenta
- Patient hospitalized in the maternal-fetal pathology of the Lille University Hospital Service
- Presence of IUGR, Death in Utero or severe preeclampsia with fetal repercussion
- A gestational age corresponding to one of the cases (pairing ± 1 week)
- No chronic intervillositis after pathological examination of the placenta
Who cannot join
- Twin pregnancy
- Liver disease in the interrogation
- Lack of consent of the patient
- Patient not covered by a social security scheme
- Patient minor
- Patient under guardianship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Search Elevated Serum Alkaline Phosphatase as a Marker of Prenatal Intervillositis Chronic Histiocytic (IHC)
Background : Chronic histiocytic intervillositis is a rare placental disease linked with poor perinatal outcome. In a recent study, a major antenatal increased alkaline phosphatase was suspected in patients affected by chronic histiocytic intervillositis. This increase may correspond to the release of alkaline phosphatase by the syncytiotrophoblaste prejudiced in this pathology.
Aim : To confirm the association between high levels of alkaline phosphatase and the occurrence of chronic histiocytic intervillositis.
Read the detailed description
Single-center study of case-control comparing three groups of patients matched for gestational age at the time of sampling. The case group will be composed of patients who experienced chronic histiocytic intervillositis which an alkaline phosphatase assay is available during pregnancy (retrospective recruitment). Two control groups will be prospectively: The first will include patients whose pregnancy is low risk. The second will consist of pathological pregnancies (IUGR, Preeclampsia and Death In Utero). All patients will have a blood sample with determination of serum alkaline phosphatase activity and examination of the placenta at delivery.
- Conditions
- Chronic Histiocytosis
- Keywords
- chronic histiocytic intervillositis, serum alkaline phosphatase, placenta, case-control study
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 |
|---|---|---|
| Cases | Patients with chronic histiocytic intervillositis during pregnancy followed at University Hospital of Lille. Alkaline phosphatase assay was performed during pregnancy and is documented in the medical record. The cases are included retrospectively. | |
| Low-risk pregnancy | Patients with a low risk pregnancy followed at University Hospital of Lille and recruited prospectively in prenatal consultation. These patients have no pathological obstetric history. | |
| High-risk pregnancy | Patients with severe pregnancy complication (IUGR, Preeclampsia or Death in Utero), but without chronic intervillositis, and hospitalized in the maternal-fetal pathology department of the University Hospital of Lille. They are recruited prospectively. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with alkaline phosphatase levels greater than or equal to 5 times the normal
Measured: At the time of inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2016 (estimated)
- Study start16 Apr 2016
- Primary completion11 Apr 2017
- Study completion11 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic HistiocytosisStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Damien Subtil, MD, PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02668120
- Sponsor's protocol ID
- 2013_18
- Other IDs
- 2014-A01550-47
- Acronym
- IHC
- Status last verified
- Oct 2018
- First submitted
- 26 Jan 2016
- Last updated
- 15 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Marchaudon V, Devisme L, Petit S, Ansart-Franquet H, Vaast P, Subtil D. Chronic histiocytic intervillositis of unknown etiology: clinical features in a consecutive series of 69 cases. Placenta. 2011 Feb;32(2):140-5. doi: 10.1016/j.placenta.2010.11.021. Epub 2010 Dec 22.
PubMed 21183219
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Search Elevated Serum Alkaline Phosphatase as a Marker of Prenatal Intervillositis Chronic Histiocytic (IHC)
- ClinicalTrials.gov ID
- NCT02668120
- Acronym / sponsor ID
- IHC / 2013_18
- Conditions
- Chronic Histiocytosis
- Keywords
- chronic histiocytic intervillositis, serum alkaline phosphatase, placenta, case-control study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 16 Apr 2016 (actual)
- Primary completion
- 11 Apr 2017 (actual)
- Study completion
- 11 Apr 2017 (actual)
- First posted
- 29 Jan 2016 (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.
Background : Chronic histiocytic intervillositis is a rare placental disease linked with poor perinatal outcome. In a recent study, a major antenatal increased alkaline phosphatase was suspected in patients affected by chronic histiocytic intervillositis. This increase may correspond to the release of alkaline phosphatase by the syncytiotrophoblaste prejudiced in this pathology.
Aim : To confirm the association between high levels of alkaline phosphatase and the occurrence of chronic histiocytic intervillositis.
Detailed description
Single-center study of case-control comparing three groups of patients matched for gestational age at the time of sampling. The case group will be composed of patients who experienced chronic histiocytic intervillositis which an alkaline phosphatase assay is available during pregnancy (retrospective recruitment). Two control groups will be prospectively: The first will include patients whose pregnancy is low risk. The second will consist of pathological pregnancies (IUGR, Preeclampsia and Death In Utero). All patients will have a blood sample with determination of serum alkaline phosphatase activity and examination of the placenta at delivery.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cases | – | –Patients with chronic histiocytic intervillositis during pregnancy followed at University Hospital of Lille. Alkaline phosphatase assay was performed during pregnancy and is documented in the medical record. The cases are included retrospectively. |
| Low-risk pregnancy | – | –Patients with a low risk pregnancy followed at University Hospital of Lille and recruited prospectively in prenatal consultation. These patients have no pathological obstetric history. |
| High-risk pregnancy | – | –Patients with severe pregnancy complication (IUGR, Preeclampsia or Death in Utero), but without chronic intervillositis, and hospitalized in the maternal-fetal pathology department of the University Hospital of Lille. They are recruited prospectively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patient pregnant following at the Lille University Hospital. The case group will be composed of patients who experienced chronic histiocytic intervillositis. Two control groups will be prospectively: The first will include patients whose pregnancy is low risk. The second will consist of pathological pregnancies (IUGR, Preeclampsia and Death In Utero).
Key inclusion criteria (15 listed)
- Patient aged 18 years or more
- Having signed a free and informed consent
- Enjoying a social security scheme
- Patient who gave birth at the Lille University Hospital between 2000 and 2009.
- Lesion of intervillositis chronic histiocytic (IHC) diagnosed during histological examination of the placenta.
Key exclusion criteria (6 listed)
- Twin pregnancy
- Liver disease in the interrogation
- Lack of consent of the patient
- Patient not covered by a social security scheme
- Patient minor
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
Number of subjects with alkaline phosphatase levels greater than or equal to 5 times the normal
Time frame: At the time of inclusion
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 15 Oct 2018.
- Background: PubMed 21183219Marchaudon V, Devisme L, Petit S, Ansart-Franquet H, Vaast P, Subtil D. Chronic histiocytic intervillositis of unknown etiology: clinical features in a consecutive series of 69 cases. Placenta. 2011 Feb;32(2):140-5. doi: 10.1016/j.placenta.2010.11.021. Epub 2010 Dec 22.
- 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.
Damien Subtil, MD, PhD principal investigator
University Hospital, Lille
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 Chronic Histiocytosis, 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 15 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: finished, as of the sponsor's last update on 15 Oct 2018. 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.
What does the primary outcome measure?
Number of subjects with alkaline phosphatase levels greater than or equal to 5 times the normal (time frame: At the time of inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02668120, which also lists 1 linked publication.
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 15 Oct 2018.