Ignite Creation Date:
2024-05-06 @ 12:53 AM
Last Modification Date:
2024-10-26 @ 10:56 AM
Study NCT ID:
NCT01687842
Status:
COMPLETED
Last Update Posted:
2019-11-18
First Post:
2012-09-06
Brief Title:
Social Cognition and Turner Syndrome
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Social Cognition and Turner Syndrome
Status:
COMPLETED
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COGNITUR
Brief Summary:
Monocentric multidisciplinary study psychologists endocrinologists psychiatrists and molecular biologists to characterize social cognition in adolescents with Turner syndrome TS
Inclusion criteria
Turner syndrome with homogeneous 45X karyotype
Age between 8 and 18 years
Somatic state compatible with the evaluation
Functional language and IQ 80 for the transfer tests
Informed consent signed by the holders of parental authority the patient and the mother for her own participation DNA collection
Affiliation to Social Security beneficiary or assignee
The primary endpoint will be the overall score to the AQ Autism Quotient questionnaire and to the SRS Social Reciprocity Scale in comparison to the expected scores for the general population For patients with scores above the threshold for SRS or QA validation of a possible diagnosis of autism spectrum disorders will be performed with commonly used diagnostic tools ADIR Lord et al 1994 ADOS-G Lord et al 1999 and diagnostic criteria of DSM IV-TR
Secondary criteria will include the results of standardized tests to assess autistic features AQ ADI-R ADOS DSM IV-TR criteria intellectual efficiency Wechsler scales psychiatric comorbidities Kiddie-SADS and sociocognitive profile SpeX test Social cognition Perception eXecutive functions
A DNA sample will be collected from the patient and her mother The observation period is 2 days for the patient and about 1 hour for the mother The total duration of the study is 3 years
Inclusion criteria
Turner syndrome with homogeneous 45X karyotype
Age between 8 and 18 years
Somatic state compatible with the evaluation
Functional language and IQ 80 for the transfer tests
Informed consent signed by the holders of parental authority the patient and the mother for her own participation DNA collection
Affiliation to Social Security beneficiary or assignee
The primary endpoint will be the overall score to the AQ Autism Quotient questionnaire and to the SRS Social Reciprocity Scale in comparison to the expected scores for the general population For patients with scores above the threshold for SRS or QA validation of a possible diagnosis of autism spectrum disorders will be performed with commonly used diagnostic tools ADIR Lord et al 1994 ADOS-G Lord et al 1999 and diagnostic criteria of DSM IV-TR
Secondary criteria will include the results of standardized tests to assess autistic features AQ ADI-R ADOS DSM IV-TR criteria intellectual efficiency Wechsler scales psychiatric comorbidities Kiddie-SADS and sociocognitive profile SpeX test Social cognition Perception eXecutive functions
A DNA sample will be collected from the patient and her mother The observation period is 2 days for the patient and about 1 hour for the mother The total duration of the study is 3 years
Detailed Description:
Patients will be recruited to the study by their pediatric endocrinologist during routine monitoring visits They will then be contacted by phone or by mail for an appointment with their mother for more oral and written information consisting of an information notice and informed consent form The recruitment of Turner syndrome patients will be based on the Reference Centre for Rare Endocrine Growth Disorders AP-HP Robert Debré Armand Trousseau and Necker hospitals
The parental origin of the remaining X chromosome will be analyzed using microsatellite analysis and comparison of the profile of the patient and her mother
Statistical analysis will be conducted under the supervision of Professor C ALBERTI using commonly accepted standards All tests will be bilateral Given the exploratory nature of the study a significance threshold of 10 will be used Statistical analyzes will be performed using SAS software V 92
The parental origin of the remaining X chromosome will be analyzed using microsatellite analysis and comparison of the profile of the patient and her mother
Statistical analysis will be conducted under the supervision of Professor C ALBERTI using commonly accepted standards All tests will be bilateral Given the exploratory nature of the study a significance threshold of 10 will be used Statistical analyzes will be performed using SAS software V 92
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ID RCB 2012-A00488-35 | OTHER | ID RCB | None |