NCT06550635

Brief Summary

Noonan's syndrome is a rare genetic disease, estimated to be between 1: 1000 to 1: 2500 and characterized by cardiothoracic malformations, sometimes mental retardation, but also by hematologic abnormalities and joint involvement. These are poorly described in the literature. The aim of this work is therefore to describe the frequency and type of these manifestations in the French pediatric population and to compare patients with and without these disorders.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2019

Shorter than P25 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 5, 2019

Completed
27 days until next milestone

Study Start

First participant enrolled

July 2, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2020

Completed
4.4 years until next milestone

First Posted

Study publicly available on registry

August 13, 2024

Completed
Last Updated

August 13, 2024

Status Verified

June 1, 2020

Enrollment Period

9 months

First QC Date

June 5, 2019

Last Update Submit

August 8, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Description of joint and hematologic disorders in patients with Noonan syndrome clinically confirmed by Van der Burgt criteria.

    Joint disorders

    Inclusion (Day 0)

  • Description of joint and hematologic disorders in patients with Noonan syndrome clinically confirmed by Van der Burgt criteria.

    hematologic disorders

    Inclusion (Day 0)

Secondary Outcomes (2)

  • Comparison of patients with and without joint involvement.

    Inclusion (Day 0), Each year

  • Comparison of patients with and without joint involvement.

    Inclusion (Day 0), Each year

Eligibility Criteria

Age0 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

French pediatric population, followed for a syndrome of Noonan clinically confirmed by the criteria of Van der Burgt.

You may qualify if:

  • Patients ≤ 20 years at the time of diagnosis
  • Noonan syndrome confirmed by van der Burgt score
  • At least one consultation in the participating center

You may not qualify if:

  • Patient \> 20 years old at the time of diagnosis
  • Absence of diagnostic criteria for van der Burgt's Noonan syndrome
  • Other rasopathies
  • Genetic mutations of MEK1, MEK2 and HRAS (which are associated with cardi-faci-cutaneous syndrome and Costello syndrome)
  • Refusal of participation in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

CHRU de Brest

Brest, 29609, France

Location

CHU de Caen

Caen, 14033, France

Location

CHU de Nantes

Nantes, 44093, France

Location

CHU de Toulouse

Toulouse, 31000, France

Location

MeSH Terms

Conditions

Noonan Syndrome

Condition Hierarchy (Ancestors)

Craniofacial AbnormalitiesMusculoskeletal AbnormalitiesMusculoskeletal DiseasesHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2019

First Posted

August 13, 2024

Study Start

July 2, 2019

Primary Completion

March 28, 2020

Study Completion

March 28, 2020

Last Updated

August 13, 2024

Record last verified: 2020-06

Locations