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Epidemiological Survey and Genetic Analysis of AD Patients in Hong Kong

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ClinicalTrials.gov Identifier: NCT04154839
Recruitment Status : Recruiting
First Posted : November 7, 2019
Last Update Posted : November 7, 2019
Sponsor:
Collaborator:
The Hong Kong Polytechnic University
Information provided by (Responsible Party):
Dr. Mandy Chan, The University of Hong Kong

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.


Condition or disease
Atopic Dermatitis Genetic Skin Disease Eczema

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Study Type : Observational
Estimated Enrollment : 450 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Pilot Study: Epidemiological Survey and Genetic Analysis of Patients With Atopic Dermatitis in Hong Kong
Actual Study Start Date : July 12, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Group/Cohort
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



Primary Outcome Measures :
  1. Significant SNPs [ Time Frame: through study completion, an average of 1 year ]
    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.


Biospecimen Retention:   Samples With DNA
Blood sample in K2EDTA and SST tubes and/or buccal swab


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04154839


Contacts
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Contact: Mandy Chan, MBBS +852 22554244 chanwmm@hku.hk
Contact: Judy Sham, MCoun +852 22556489 js83213@hku.hk

Locations
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Hong Kong
Department of Medicine Recruiting
Central, Hong Kong
Contact: Mandy Chan, MBBS    +852 22554244    chanwmm@hku.hk   
Contact: Judy Sham, MCoun    +852 22556489    js83213@hku.hk   
Sponsors and Collaborators
The University of Hong Kong
The Hong Kong Polytechnic University
Investigators
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Principal Investigator: Mandy Chan, MBBS The University of Hong Kong
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Responsible Party: Dr. Mandy Chan, Clinical Assistant Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT04154839    
Other Study ID Numbers: UW 19-417
First Posted: November 7, 2019    Key Record Dates
Last Update Posted: November 7, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share individual participant data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Mandy Chan, The University of Hong Kong:
Atopic dermatitis
Genetics
Eczema
Epidemiology
Additional relevant MeSH terms:
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Dermatitis, Atopic
Skin Diseases, Genetic
Dermatitis
Eczema
Skin Diseases
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases