Actively Recruiting

Age: 2Years - 35Years
All Genders
ID07464821

National Multicentre Study on Lipid Profile in Noonan Syndrome and Related Disorders: Trends by Age, Gender and Genotype

Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2026-03-11

200

Participants Needed

14

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

RASopathies, including Noonan syndrome and related disorders, are congenital conditions marked by physical differences, heart defects, bone anomalies, cognitive challenges, and varying risks of pediatric cancers. These conditions involve a shared disruption of the RAS-MAPK pathway and show changes in energy metabolism, such as reduced body fat and feeding problems. This research investigates the lipid and glucose metabolism in individuals with these conditions to improve understanding and patient care. This observational study examines how lipid profiles and glucose metabolism vary by sex, age (pre- and post-puberty), and genetic subtype in patients with RASopathies. The study tracks these metabolic factors at multiple time points: baseline, 1 year, 2 years, 5 years, and 10 years. Researchers also compare altered lipid levels with associated proteins apo-B and apo-A1 in different forms of RASopathy. Participants aged 2 to 35 years with a confirmed molecular diagnosis of a RASopathy are enrolled. Data collection includes metabolic assessments at scheduled visits over up to 10 years. The main outcome measures focus on changes in lipid and glucose metabolism related to demographics and genotype. The study aims to define the natural history of lipid and glucose changes to support better clinical management for patients.

CONDITIONS

Brief Title

National Multicentre Study on Lipid Profile in Noonan Syndrome and Related Disorders: Trends by Age, Gender and Genotype

Who Can Participate

Age: 2Years - 35Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Clinically diagnosed RASopathy confirmed by molecular testing
  • Patients referred to participating centers between 01/01/2001 and 31/12/2022
  • Age at enrollment between 2 and 35 years, inclusive
  • Obtaining informed consent
Not Eligible

You will not qualify if you...

  • None

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 10 years

Participants undergo scheduled assessments to monitor lipid and glucose metabolism over time to understand the natural history of RASopathies.

5 visits over 10 years (baseline, 1 year, 2 years, 5 years, and 10 years)

Trial Site Locations

Total: 14 locations

1

Azienda Ospedaliero-Universitaria di Alessandria

Alessandria, Italy

Not Yet Recruiting

2

AOU Policlinico di Bari

Bari, Italy

Not Yet Recruiting

3

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Italy

Actively Recruiting

4

AOU Meyer IRCCS

Florence, Italy

Actively Recruiting

5

IRCCS Istituto Giannina Gaslini

Genova, Italy

Actively Recruiting

6

AOU Policlinico G. Martino

Messina, Italy

Not Yet Recruiting

7

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Italy

Not Yet Recruiting

8

IRCCS Ospedale San Raffaele

Milan, Italy

Not Yet Recruiting

9

Azienda Ospedaliera Policlinico di Modena

Modena, Italy

Not Yet Recruiting

10

Fondazione IRCCS San Gerardo dei Tintori

Monza, Italy

Not Yet Recruiting

11

AOU Vanvitelli

Naples, Italy

Not Yet Recruiting

12

Azienda Ospedale-Università di Padova

Padova, Italy

Not Yet Recruiting

13

Azienda Ospedaliero-Universitaria di Parma

Parma, Italy

Not Yet Recruiting

14

AOUI-VR Azienda Ospedaliero-Universitaria Integrata di Verona

Verona, Italy

Not Yet Recruiting

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Research Team

F

Federica Tamburrino

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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