Abnormality of the NeckCGH ArrayNCT03239002
Antenatal Detection by Array CGH Genomic Rearrangements Unbalanced Front Uninsulated Thick Neck or a Combination of Two Signs of Ultrasound Calling Normal Karyotype
An observational study of Abnormality of the Neck and Fetus; Abnormal, Affecting Management of Pregnancy, run by University Hospital, Lille at 1 site in France.
Trial summary
This is the first study with a real diagnostic and prognostic focus in prenatal. In addition to this innovative aspect, the identification of cryptic imbalances in fetuses with malformative syndrome would be an invaluable resource for the identification of new genes involved in development, as is already the case for… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Abnormality of the Neck, Fetus; Abnormal, Affecting Management of Pregnancy
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2011to Sep 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: the parturients aged 18 to 45 years for whom a karyotype performed from a trophoblast biopsy or amniotic fluid puncture is normal or apparently balanced
Who may be able to join
- a karyotype performed from a trophoblast biopsy or an amniotic fluid puncture is normal or apparently balanced.
- The fetuses included in the study should have one of the following two criteria:
- 1) Thick bone (greater than 99th percentile, between week 11 and week 13 of amenorrhoea plus 6 days, correlated to a cranio-caudal length measured between 45 and 84 mm) detected in the first trimester of pregnancy associated with One or more echographic sign (s).
- 2) At least two ultrasound call signs involving the following organs (heart, kidney, brain, limbs, digestive tract, face) or intrauterine growth retardation (less than 3rd percentile) associated with one of these Signs of appeal.
Who cannot join
- The parturientes in emergency situation,
- Benefiting from a legal protection (guardianship / curatorship)
Trial locations and contacts
1 site in 1 country.
About this study
This is the first study with a real diagnostic and prognostic focus in prenatal. In addition to this innovative aspect, the identification of cryptic imbalances in fetuses with malformative syndrome would be an invaluable resource for the identification of new genes involved in development, as is already the case for postnatal studies.
This research aims to:
- to test the feasibility of this protocol, ie the practical application of this new technology in the context of prenatal diagnosis,
- demonstrate and evaluate the possible involvement of cryptic chromosomal abnormalities in fetuses with a thick neck associated with other malformations and recruited on the strict criteria mentioned above,
- assist in the diagnosis of these fetuses and genetic information for their families,
- identify new regions of the genome potentially involved in the occurrence of congenital malformations.
- Medical subject headings
- Antisocial Personality Disorder
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patient with Ultrasound call signs (thick neck and / or any other organ concerned)
Measured: During the first trimester of pregnancy
Secondary outcomes (1)
CGH-array analysis
CGH-array result: normal, deletion or duplication, de novo or inherited, size, type and number of genes involved
Measured: During the first trimester of pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2017
- Study startJul 2011
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abnormality of the NeckStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Véronique HOUFFLIN-DEBARGE, MD, PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03239002
- Sponsor's protocol ID
- 2010_24
- Other IDs
- 2011-A00105-36
- Acronym
- CGH Array
- Status last verified
- Jan 2018
- First submitted
- 31 Jul 2017
- Last updated
- 30 Jan 2018
- 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 30 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antenatal Detection by Array CGH Genomic Rearrangements Unbalanced Front Uninsulated Thick Neck or a Combination of Two Signs of Ultrasound Calling Normal Karyotype
- ClinicalTrials.gov ID
- NCT03239002
- Acronym / sponsor ID
- CGH Array / 2010_24
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Jul 2011
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 3 Aug 2017 (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.
This is the first study with a real diagnostic and prognostic focus in prenatal. In addition to this innovative aspect, the identification of cryptic imbalances in fetuses with malformative syndrome would be an invaluable resource for the identification of new genes involved in development, as is already the case for postnatal studies.
This research aims to:
- to test the feasibility of this protocol, ie the practical application of this new technology in the context of prenatal diagnosis,
- demonstrate and evaluate the possible involvement of cryptic chromosomal abnormalities in fetuses with a thick neck associated with other malformations and recruited on the strict criteria mentioned above,
- assist in the diagnosis of these fetuses and genetic information for their families,
- identify new regions of the genome potentially involved in the occurrence of congenital malformations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- the parturients aged 18 to 45 years for whom a karyotype performed from a trophoblast biopsy or amniotic fluid puncture is normal or apparently balanced
Key inclusion criteria (4 listed)
- a karyotype performed from a trophoblast biopsy or an amniotic fluid puncture is normal or apparently balanced.
- The fetuses included in the study should have one of the following two criteria:
- 1) Thick bone (greater than 99th percentile, between week 11 and week 13 of amenorrhoea plus 6 days, correlated to a cranio-caudal length measured between 45 and 84 mm) detected in the first trimester of pregnancy associated with One or more echographic sign (s).
- 2) At least two ultrasound call signs involving the following organs (heart, kidney, brain, limbs, digestive tract, face) or intrauterine growth retardation (less than 3rd percentile) associated with one of these Signs of appeal.
Key exclusion criteria (2 listed)
- The parturientes in emergency situation,
- Benefiting from a legal protection (guardianship / curatorship)
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 patient with Ultrasound call signs (thick neck and / or any other organ concerned)
Time frame: During the first trimester of pregnancy
1 secondary outcome
CGH-array analysis
Time frame: During the first trimester of pregnancy
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 30 Jan 2018.
- 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.
Véronique HOUFFLIN-DEBARGE, 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 Abnormality of the Neck and Fetus; Abnormal, Affecting Management of Pregnancy, 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 4 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 30 Jan 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 patient with Ultrasound call signs (thick neck and / or any other organ concerned) (time frame: During the first trimester of pregnancy). 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 30 Jan 2018.