Pregnant Women Requiring AmniocentesisDASIRUWIBENCT01842659
Prenatal Screening for Imprinting Anomalies Implicated in Beckwith Wiedemann and Silver Russell Syndromes
A study testing Methylation Index in people with Pregnant Women Requiring Amniocentesis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Losses of imprinting are involved in various syndromes. Those occurring in the 11p15 region lead to Beckwith-Wiedemann and Silver-Russell Syndromes. These losses of imprinting follow a mosaic pattern, rendering their detection difficult, especially given the scarcity of available DNA in amniotic fluid. 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
- Pregnant Women Requiring Amniocentesis
- What is being tested?
- Methylation Index
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteFrance
- Study dates
- May 2013to Oct 2016
- Phase
- Interventional
- 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
Who may be able to join
- Pregnant women, 18 years of age or older
- Requiring amniotic fluid sampling in the context of pregnancy care after 15 weeks of amenorrhea
- Having provided written informed consent
- Followed at Trousseau Hospital or Clinique des Bluets during their pregnancy
- Covered by or beneficiary of a state health insurance program (except for medical aid programs)
Who cannot join
- Warning signs on ultrasound that require a medical termination of pregnancy to be discussed even before amniocentesis is performed
Trial locations and contacts
1 site in 1 country.
About this study
Losses of imprinting are involved in various syndromes. Those occurring in the 11p15 region lead to Beckwith-Wiedemann and Silver-Russell Syndromes. These losses of imprinting follow a mosaic pattern, rendering their detection difficult, especially given the scarcity of available DNA in amniotic fluid. Thus, in spite of growing demand, prenatal diagnosis (PND) for imprinting abnormalities of the 11p15 region is not available.
The recent development of a quantitative PCR method that permits the methylation index (MI) of imprinted regions to be calculated renders PND technically possible. Nevertheless, because of the mosaic nature of these anomalies, it is essential to verify that the methylation pattern of the 11p15 region obtained from the amniotic fluid matches that obtained from the blood.
Read the detailed description
To evaluate the agreement between the methylation index of the 11p15 region obtained using DNA extracted from amniocytes and that extracted from cord blood leukocytes, by calculating the intraclass correlation coefficient (ICC).
Ancillary study :
This second part of the study aims to determine the standard of methylation index of the 11p15 region (inclusion of 100 additional patients). The use of amniotic liquid will allow to calculate :
- the average of methylation index,
- the value of the standard deviation
- the inter-assay coefficient of variation for the test-used.
- Conditions
- Pregnant Women Requiring Amniocentesis
- Being tested
- Methylation Index
- Keywords
- MI, amniocentesis, cord blood, placenta, Silver Russell Syndrome, Beckwith Wiedemann Syndrome
- Medical subject headings
- Silver-Russell Syndrome, Beckwith-Wiedemann Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylation IndexGenetic
To calculate the methylation index (MI) of imprinted regions.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women requiring amniocentesis | Experimental | Pregnant women requiring amniocentesis Receives: Genetic: Methylation Index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Methylation Index (MI) of the 11p15 region using DNA extracted
To evaluate the agreement between the MI of the 11p15 region obtained using DNA extracted from amniocytes and that extracted from cord blood leukocytes, by calculating the intraclass correlation coefficient (ICC).
Measured: 27 weeks
Secondary outcomes (1)
MI using the placenta
To calculate the MI using the placentas of the same individuals and to evaluate its agreement with the MIs obtained above.
Measured: 27 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2013 (estimated)
- Study startMay 2013
- Primary completionDec 2015
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnant Women Requiring AmniocentesisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Irene Netchine, PU-PH, Principal investigator, Assistance Publique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01842659
- Sponsor's protocol ID
- CRC 2011
- Other IDs
- AOM 11003
- Acronym
- DASIRUWIBE
- Status last verified
- Aug 2016
- First submitted
- 24 Apr 2013
- Last updated
- 24 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prenatal Screening for Imprinting Anomalies Implicated in Beckwith Wiedemann and Silver Russell Syndromes
- ClinicalTrials.gov ID
- NCT01842659
- Acronym / sponsor ID
- DASIRUWIBE / CRC 2011
- Conditions
- Pregnant Women Requiring Amniocentesis
- Keywords
- MI, amniocentesis, cord blood, placenta, Silver Russell Syndrome, Beckwith Wiedemann Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Oct 2016 (estimated)
- First posted
- 29 Apr 2013 (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.
Losses of imprinting are involved in various syndromes. Those occurring in the 11p15 region lead to Beckwith-Wiedemann and Silver-Russell Syndromes. These losses of imprinting follow a mosaic pattern, rendering their detection difficult, especially given the scarcity of available DNA in amniotic fluid. Thus, in spite of growing demand, prenatal diagnosis (PND) for imprinting abnormalities of the 11p15 region is not available.
The recent development of a quantitative PCR method that permits the methylation index (MI) of imprinted regions to be calculated renders PND technically possible. Nevertheless, because of the mosaic nature of these anomalies, it is essential to verify that the methylation pattern of the 11p15 region obtained from the amniotic fluid matches that obtained from the blood.
Detailed description
To evaluate the agreement between the methylation index of the 11p15 region obtained using DNA extracted from amniocytes and that extracted from cord blood leukocytes, by calculating the intraclass correlation coefficient (ICC).
Ancillary study :
This second part of the study aims to determine the standard of methylation index of the 11p15 region (inclusion of 100 additional patients). The use of amniotic liquid will allow to calculate :
- the average of methylation index,
- the value of the standard deviation
- the inter-assay coefficient of variation for the test-used.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women requiring amniocentesis | Experimental | Genetic: Methylation IndexPregnant women requiring amniocentesis |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Pregnant women, 18 years of age or older
- Requiring amniotic fluid sampling in the context of pregnancy care after 15 weeks of amenorrhea
- Having provided written informed consent
- Followed at Trousseau Hospital or Clinique des Bluets during their pregnancy
- Covered by or beneficiary of a state health insurance program (except for medical aid programs)
Key exclusion criteria (1 listed)
- Warning signs on ultrasound that require a medical termination of pregnancy to be discussed even before amniocentesis is performed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methylation IndexTo calculate the methylation index (MI) of imprinted regions. | Genetic | Pregnant women requiring amniocentesis |
Primary outcome
Methylation Index (MI) of the 11p15 region using DNA extracted
Time frame: 27 weeks
To evaluate the agreement between the MI of the 11p15 region obtained using DNA extracted from amniocytes and that extracted from cord blood leukocytes, by calculating the intraclass correlation coefficient (ICC).
1 secondary outcome
MI using the placenta
Time frame: 27 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2016.
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.
Irene Netchine, PU-PH principal investigator
Assistance Publique
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methylation Index in people with Pregnant Women Requiring Amniocentesis, 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 5 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 24 Aug 2016. 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?
Results are not available in the source record.
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?
Methylation Index (MI) of the 11p15 region using DNA extracted (time frame: 27 weeks). 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 24 Aug 2016.