Multi-center Registration Study of Adult Onset Still's Disease in Chinese Population

NCT03651193 | Unknown

• 1 other identifier: MAOSDC20180720
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This multi-center registration study will investigate the clinical characteristics of AOSD population in China , identify possible factors inducing the onset and active condition of AOSD in Chinese population , and identify the new high specific and sensitive markers of AOSD

Conditions

Adult Onset Still Disease

Keywords

Adult Onset Still's Disease; Chinese population

Outcome Measures

Primary Outcomes (1)

• gene expression level and methylation level

  The data of this study is managed by the Hunan Key Laboratory of Medical Epigenomics (Department of Dermatology, The Second Xiangya Hospital of Central South University). The authenticity, integrity and confidentiality of clinical data are required to be ensured, original case and case report form shall be filled out by investigator or the designated person of researcher and shall not be altered at will. If necessary, the name of the changer and the date of modification should be signed. Statistical analysis will use GraphPad Prism or SPSS software. All statistical tests will be performed using a two-sided test, P values less than 0.05 will be considered statistically significant, the confidence interval uses 95%. The measurement data will be statistically described using mean ± standard deviation or median (minimum, maximum). Disease exposure factors and impact analysis will be based on descriptive statistical analysis.

  0 day

Study Arms (2)

AOSD

Patients fulfill Japan's Yamaguch AOSD classification

Diagnostic Test: Exon sequencing and Methylated sequencing

Control

Use 1:1 group matching, should meet the following condition -s : same gender as matching case; same age as matching case or the difference ranges within 1 year; no Immune related diseases (e.g. Psor -iasis, Systemic Lupus Erythematos -us, Dermatomyositis, Scleroderma, Rheumatoid Arthritis, Type 1 Diabet -es, Behcet's disease, Sjogren's Syndrome, Hyperthyroidism, etc.); no family history of immune related diseases.

Diagnostic Test: Exon sequencing and Methylated sequencing

Interventions

Exon sequencing and Methylated sequencing DIAGNOSTIC_TEST

Exon sequencing and Methylated sequencing

AOSD; Control

Eligibility Criteria

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

Study Population

Chinese population

You may qualify if:

• AOSD: Patients fulfill Japan's Yamaguch AOSD classification.
• Control: Use 1:1 group matching, should meet the following condition -s : same gender as matching case; same age as matching case or the difference ranges within 1 year; no Immune related diseases (e.g. Psor -iasis, Systemic Lupus Erythematos -us, Dermatomyositis, Scleroderma, Rheumatoid Arthritis, Type 1 Diabet -es, Behcet's disease, Sjogren's Syndrome, Hyperthyroidism, etc.); no family history of immune related diseases.

You may not qualify if:

• Anyone with physical or mental illness that may affect the assessment will be excluded, such as patients with hearing or speech expression disorders.

Sponsors & Collaborators

• Second Xiangya Hospital of Central South University: lead

Study Sites (1)

The Second Xiangya Hospital of Central South University

Hunan, Changsha, 410011, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

whole blood 5ml，serum 1.5ml

MeSH Terms

Conditions

Still's Disease, Adult-Onset

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Qianjin Lu, MD，PHD

  Central South University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qianjin Lu, MD，PHD

CONTACT

+86-13787097676; qianlu5860@gmail.com

Yuwei Li, MD

CONTACT

+86-15200854262; yuweili@csu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director, Dept. of Dermatology, The Second Xiangya Hospital of Central South University

Study Record Dates

• First Submitted: August 27, 2018
• First Posted: August 29, 2018
• Study Start: November 28, 2018
• Primary Completion: June 30, 2022
• Study Completion: December 31, 2022
• Last Updated: February 2, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)