Register of Patients With Prader-Willi Syndrome

• Sponsor: University Hospital, Toulouse (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT02829684
• Collaborator: (none)
• Enrollment: 500
• Location: 1
• Anticipated Duration (Months): 177
• Patients Per Site Per Month: 2.8

Study Details

Study Description

Brief Summary

Prader-Willi Syndrome (PWS) is a rare syndrome with a prevalence of 15 to 20 000 at birth. PWS represents a large fraction of mental retardation syndromes due to a genetic cause and the most frequent cause of genetic obesity. The majority of the patients are seen by paediatricians. This syndrome is responsible for severe physical, psychological and social impairments.

The diversity and the severity of the manifestations of this disease explain the requirement of multidisciplinary care which deserve specific evaluation. Today the follow-up and management of a great proportion of these patients are greatly insufficient if not absent.

Teams strongly lack information on the natural history of this severe disease and on the factors involved in its evolution and the outcome of these patients throughout life. The present project is to implement a register in the whole country for children and adult patients

Condition or Disease	Intervention/Treatment	Phase
Prader-Willi Syndrome	Other: Data collection

Study Design

• Study Type: Observational
• Anticipated Enrollment: 500 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Implementation of a National Register of Children and Adults Presenting Prader-Willi Syndrome
• Actual Study Start Date: Mar 1, 2009
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 1, 2023

Outcome Measures

Primary Outcome Measures

1. collect data about patients [Baseline]

   Circumstances of diagnosis, genetic diagnosis, modalities of follow-up and clinical management and a questionnaire to evaluate quality of life of the family and social data

Secondary Outcome Measures

1. collect data about patients [During 10 years at least]

   modalities of follow-up and clinical management and a questionnaire to evaluate quality of life of the family and social data

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• all subjects with a Prader-Willi Syndrome

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital of Children	Toulouse		France	31059

Sponsors and Collaborators

• University Hospital, Toulouse

Investigators

• Principal Investigator: Tauber Maité, MD, University Hospital, Toulouse

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Toulouse
• ClinicalTrials.gov Identifier: NCT02829684
• Other Study ID Numbers: 07 315 03
• First Posted: Jul 12, 2016
• Last Update Posted: Aug 27, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Prader-Willi Syndrome; Syndrome

Study Results

No Results Posted as of Aug 27, 2021