- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02890472
Prenatal Examination of Deletion 22q11 Syndrome : Thymic Dysgenesis THYMI Study
January 26, 2021 updated by: Centre Hospitalier Universitaire de Nīmes
Research of Thymix Dysgenesis in Prenatal Examination of Deletion 22q11 Syndrome
22q11.2 microdeletion seems the prenatally under-diagnosed .
Indeed , there is a mismatch between the series on the heart rate of 22q11.2
antenatal 84% against 30% in the adult series despite a perinatal mortality of 16% suggesting opportunities for improvement in the prenatal diagnosis of fetus with a microdeletion 22q11.2
, especially without heart disease
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
13
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Nîmes, France
- CHUNimes
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
prenatal diagnosis of a fetal 22q11 deletion syndrome
Description
Inclusion Criteria:
- all prenatal diagnosis with FISH or CGH array of a fetal 22q11 deletion syndrome during the inclusion period.
- The pregnancy follow-up should be done one of the 44 french fetal medicine unit.
- Sonographic picture of 3 vessels slides should be communicated for independent review.
Exclusion Criteria:
- no sonographic picture available
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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prenatal diagnosis of a fetal 22q11 deletion syndrome
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Thymic thoracic ratio " measurement on sonographic picture of the fetal 3 vessels slides will be done by independent investigator.
Time Frame: day 0
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day 0
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2017
Primary Completion (Actual)
July 1, 2020
Study Completion (Actual)
December 31, 2020
Study Registration Dates
First Submitted
August 26, 2016
First Submitted That Met QC Criteria
August 31, 2016
First Posted (Estimate)
September 7, 2016
Study Record Updates
Last Update Posted (Actual)
January 27, 2021
Last Update Submitted That Met QC Criteria
January 26, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Lymphatic Diseases
- Endocrine System Diseases
- Disease
- Congenital Abnormalities
- Genetic Diseases, Inborn
- Musculoskeletal Diseases
- Parathyroid Diseases
- Heart Defects, Congenital
- Cardiovascular Abnormalities
- Craniofacial Abnormalities
- Musculoskeletal Abnormalities
- Abnormalities, Multiple
- Chromosome Disorders
- Lymphatic Abnormalities
- Hypoparathyroidism
- Syndrome
- DiGeorge Syndrome
- 22q11 Deletion Syndrome
Other Study ID Numbers
- LOCAL/2015/EM-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Washington University School of MedicineDickson, Patricia I., M.D.; Milbrandt, Jeffrey, MD, PhD; Mitra, Rob, PhD; Turner...RecruitingChromosome 9P Deletion Syndrome | 9p Minus Syndrome | Alfi Syndrome | 9P Monosomy | 9P Partial Monosomy SyndromeUnited States
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