Determinants of Health Status and Quality of Life in Patients With Primary Immunodeficiencies Inhereted Diagnosed During Childhood

Primary Immune Deficiency Clinical Trial

— CEREDIH  

Official title:

Determinants of Health Status and Quality of Life in Patients With Primary Immunodeficiencies Inhereted Diagnosed During Childhood

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02868333
• Other study ID #: 2012-10
• Secondary ID: 2012-A00338-35
• Status: Active, not recruiting
• Phase: N/A
• First received: August 11, 2016
• Last updated: August 11, 2016
• Start date: May 2012
• Est. completion date: January 2017

Study information

• Verified date: August 2016
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical Trial Summary

Background: Most children with primary immune deficiency (PID) now reach adulthood. However, few studies have evaluated their health status and health related quality of life (HRQoL).

Objective: To investigate long-term morbidity, the French Reference Center for PIDs initiated a prospective multicenter cohort: the F-CILC (French Childhood Immune deficiency Long-term Cohort). The data collected will be used to assess the physical health condition of patients who reached adulthood and the impact on their quality of life.

Methods: Patients are asked to complete health status questionnaires. A severity score (grade1 ["mild"] to grade 4 ["life-threatening"]) is assigned to each health condition. The HRQoL of patients is compared to age- and sex-matched French normal values using the SF36 HRQoL questionnaire.

Capsule summary. This will be the first study of adult survivors of childhood PID describing how the burden of health conditions affect their quality of life.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1780
• Est. completion date: January 2017
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patient with primary immune deficiency diagnosed during childhood

Exclusion Criteria:

• Patients not willing to answer to quality of life questionnaires

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Immunologic Deficiency Syndromes
• Primary Immune Deficiency

Locations

Country	Name	City	State
France	Assistance Publique Hôpitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numbers of patient with PID diagnosed during childhood experiencing a heavy burden of health conditions affecting their quality of life		3 years	No