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

NCT02868333 | Unknown

• 2 other identifiers: 2012-102012-A00338-35
• Study Type: observational
• Target: 1,780
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Primary Immune Deficiency

Outcome Measures

Primary Outcomes (1)

• Numbers of patient with PID diagnosed during childhood experiencing a heavy burden of health conditions affecting their quality of life

  3 years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with primary immune deficiency diagnosed during childhood and followed in refereries center for this desease

You may qualify if:

• Patient with primary immune deficiency diagnosed during childhood

You may not qualify if:

• Patients not willing to answer to quality of life questionnaires

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hôpitaux de Marseille

Marseille, 13354, France

Location

Related Publications (1)

• Barlogis V, Mahlaoui N, Auquier P, Fouyssac F, Pellier I, Vercasson C, Allouche M, De Azevedo CB, Moshous D, Neven B, Pasquet M, Jeziorski E, Aladjidi N, Thomas C, Gandemer V, Mazingue F, Picard C, Blanche S, Michel G, Fischer A. Burden of Poor Health Conditions and Quality of Life in 656 Children with Primary Immunodeficiency. J Pediatr. 2018 Mar;194:211-217.e5. doi: 10.1016/j.jpeds.2017.10.029. Epub 2017 Dec 6.

  PMID: 29198545 DERIVED

MeSH Terms

Conditions

Primary Immunodeficiency Diseases

Condition Hierarchy (Ancestors)

Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Urielle DESALBRES

  Assistance Publique Hôpitaux de Marseille

  STUDY DIRECTOR

• Vincent BARLOGIS, MD

  Assistance Publique Hôpitaux de Marseille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2016
• First Posted: August 16, 2016
• Study Start: May 1, 2012
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2017
• Last Updated: August 16, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)