Epidemiological Survey and Genetic Analysis of AD Patients in Hong Kong

NCT04154839 | Unknown

• 1 other identifier: UW 19-417
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

This is a joint research study between The Hong Kong Polytechnic University (PolyU) and The University of Hong Kong (HKU) as titled above. In view of the increasing prevalence of atopic dermatitis (AD), the lack of complete epidemiology data on childhood and adult AD in Hong Kong and the lack of complete understanding on the genetic and environmental factors associated with it, the purpose of this study to carry out an epidemiology and genetic study that targets AD patients within the local Hong Kong population. The investigators will search for new AD-associated genetic variants that are related to the local population and believe that the genetic profiles that arise from this project will form an important basis for the future management and treatment of AD, such as disease-risk screening strategy and therapeutic target development.

Conditions

Atopic Dermatitis; Genetic Skin Disease; Eczema

Keywords

Atopic dermatitis; Genetics; Eczema; Epidemiology

Outcome Measures

Primary Outcomes (1)

• Significant SNPs

  The significant single nucleotide polymorphisms (SNPs) between control group and different AD case subgroups (different age of onset, different AD severity, different relapsing status), Cochran-Armitage trend test will be used to assess statistical significance of the association with each SNP, and Mantel-Haenszel method for two 2 × 2 allele frequency tables will be used to assess association of SNPs on chromosome X within male and female subjects.

  through study completion, an average of 1 year

Study Arms (2)

Atopic dermatitis group

Number of subjects in atopic dermatitis group 0 - \< 6 years : 50 subjects 6 - \<12 years : 50 subjects 12 - \<18 years : 50 subjects Adult (\>= 18 years) : 150 subjects Total no. of cases: 300 cases

Control group

\>= 40 yrs : 150 subjects

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

For AD cases: Chinese-Han AD subjects who was born in Hong Kong For Control: Chinese-Han subjects who was born in Hong Kong aged more or equal to 40 Years

You may qualify if:

• Normal controls (Recruited in Poly U)
• Aged more or equal to 40 \[Age of 40 is chosen as an arbitrary cutoff because studies had shown that the peak incidence among adult-onset AD cases occurs at age 20-40 years (Silvestre Salvador et al., 2017). Controls have been chosen more or equal to 40 years of age as they would likely have developed AD by the age of 40.
• Subjects that do not have a history of AD, personal history and family history of AD including first-, second-, and third-degree relatives;
• Subjects without a personal history and/or family history of other allergic and atopic disorders such as autoimmune diseases, skin disorders and systemic diseases.
• Born in Hong Kong and Chinese-Han
• AD cases (Recruited from QMH and TWH)
• Patients have to be clinically diagnosed by a qualified dermatologist on the basis of a skin examination diagnosed according to Hanifin and Rajka criteria.
• Children cases should be aged \< 18 at the time of recruitment and adult cases should be aged 18 at the time of recruitment;
• Born in Hong Kong and Chinese-Han

You may not qualify if:

• Non-Chinese or non-local case and control subjects;
• Either of the parents are non-Chinese;
• Case and control subjects who do not speak or understand Cantonese or Chinese;
• Age \<40 for control subjects;
• Subjects who are pregnant;
• Unable to provide signed informed consent.

Sponsors & Collaborators

• The University of Hong Kong: lead
• The Hong Kong Polytechnic University: collaborator

Study Sites (1)

Department of Medicine

Central, Hong Kong

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample in K2EDTA and SST tubes and/or buccal swab

MeSH Terms

Conditions

Dermatitis, Atopic; Skin Diseases, Genetic; Eczema

Condition Hierarchy (Ancestors)

Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Mandy Chan, MBBS

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: October 29, 2019
• First Posted: November 7, 2019
• Study Start: July 12, 2019
• Primary Completion: December 31, 2021
• Study Completion: June 30, 2022
• Last Updated: May 5, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)