Genetic Research of Monogenic Obesity in a Pediatric Coho... | NCT05362565

Studies
Genetic Research of Monogenic Obesity in a Pediatric Cohort With Severe and Early Onset Obesity

NCT05362565

Sponsor

University Hospital, Bordeaux

Status

Unknown status

Last Update Posted

May 5, 2022Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Monogenic Obesity

Interventions

Salivary Sampling

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2022Estimated

Primary Completion Date

Oct 1, 2023Estimated

Completion Date

Jan 1, 2024Estimated

First Submitted Date

May 2, 2022

First Submission Date that Met QC Criteria

May 2, 2022

First Posted Date

May 5, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 2, 2022

Last Update Posted Date

May 5, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Obesity is a frequent disease mainly caused by environmental/polygenic factors and more rarely caused by the alteration of a single gene ("monogenic obesity"). The diagnosis of these rare forms can lead to personalized management (new treatments, prognosis, adapted hygienic and dietary rules) and family screening. The use of a panel covering the known causes of monogenic obesity on a pediatric cohort of severe and early obesity will allow to evaluate the relevance of these analyses to adapt the management of this type of patients.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patient with salivary sampling			Biological: Salivary Sampling

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Salivary Sampling	Biological	The DNA study will be carried out from saliva sample 1 saliva sample per patient will be performed at the inclusion visit	Patient with salivary sampling

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Positivity rate of patients for whom a diagnosis of monogenic obesity will be obtained when all analyses have been performed.		Inclusion visit

Secondary Outcomes

Measure	Description	Time Frame
Number of Patients eligible for a drug targeting single-gene obesity		Inclusion visit
Number of patients for whom a genetic finding will have changed management and description of changes.		Inclusion visit

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Recruitment age: 2-17 years
Body mass index, greater than the International Obesity Task Force (IOTF) 30 curve before the age of 5
Care at the specialized pediatric obesity center (CSO) of the Bordeaux University Hospital
Informed consent signed

Exclusion Criteria:

no informed consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Patient with a Body mass index, greater than the International Obesity Task Force (IOTF) 30 curve before the age of 5.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Louis LEBRETON	Contact	05 57 82 21 78		louis.lebreton@chu-bordeaux.fr
Wafae BELCADI	Contact			wafae.belcadi@chu-bordeaux.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Hospitalier Universitaire de Bordeaux		Bordeaux		33400	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D030342	Genetic Diseases, Inborn

Ancestor Terms

ID	Term
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided