Bidirectional Cohort Study of Nanfang Spondyloarthritis

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

Spondyloarthritis(SpA) patients attending Nanfang Hospital of Southern Medical University will generate a large number of clinical condition scales, laboratory indicators, imaging data such as X-rays or MRIs in the course of multiple standardized follow-up visits, as well as medical specimens from some of the patients who undergo surgical treatments. The Department of Orthopaedic Surgery of Nanfang Hospital is looking forward to the future and proposes to establish a specialized cohort named Nanfang SpA Bidirectional Specialized Disease Cohort by simply recording the clinical and imaging data of the above patients who have attended the clinic, been treated routinely, and have been followed up in the department without any interventional research measures. The cohort is proposed to: (1) archive the disease characteristics, biochemical index data, and disease assessment scales of all SpA patients attending the Southern Hospital; (2) record the X-ray and magnetic resonance imaging data of the patients to establish the Southern SpA Imaging Dataset. This provides strong support for subsequent SpA research projects and lays the foundation for subsequent large-scale transect studies and retrospective studies.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 10
Maximum Age: 59
Healthy Volunteers: f
View:

• 1.Attended Nanfang Hospital, Southern Medical University, 2010-2030 2.Prospective cohort study component: subjects voluntarily participate with informed consent and sign an informed consent form 3.Retrospective cohort study: (i) patients who visited the hospital from April 2010 to April 2024 (and who will not return to the hospital at a later date) were exempted from informed consent; (ii) patients who visited the hospital from May 2024 to April 2025 were required to sign an informed consent 4.10 years old ≤ age ≤ 59 years old 5.Patients with a standardized diagnosis of spondyloarthritis by the following guidelines or diagnostic criteria, i.e., meeting one of the following diagnostic criteria: (1) 2009 ASAS classification criteria for axial spondyloarthritis; (2) 2011 ASAS classification criteria for peripheral spondyloarthritis

Locations
Other Locations
China
Nanfang Hostipal,Southern Medical University
RECRUITING
Guangzhou
Contact Information
Primary
Jun Xiao, Dr
orthopaedxj@163.com
0086-20-18665000156
Time Frame
Start Date: 2025-05-17
Estimated Completion Date: 2030-04-30
Participants
Target number of participants: 3000
Treatments
Retrospective cohort
Patients between May 2024 and April 2025 were required to sign an up-to-date Ethics Committee-approved Informed Consent Form (ICF) prior to data collection, and all clinical data were collected at once. Patients with visits from April 2010 to April 2024 (and who will not return to the hospital at a later date) will be exempted from informed consent for this study, as the information involved in the visit will come from the medical record of the clinical visit, the risk to the subject is no more than minimal, the exemption from informed consent will not adversely affect the patient's rights or health and the study will not be able to proceed if informed consent is obtained, and subjects' privacy and personally identifiable information will be protected. Subjects' privacy and personally identifiable information will be protected.
Prospective cohort
Patients will be required to sign an up-to-date Ethics Committee-approved Informed Consent Form (ICF) prior to data collection. After obtaining informed consent from patients, information on routine clinical visits will be collected, and the number and timing of study visits will follow the time points for routine clinical patient review. The time points for routine clinical review will be: every 3 months for 1 year and every 6 months for 3 years after treatment, for a total of 4 years.
Related Therapeutic Areas
Sponsors
Collaborators: Southern Medical University, China
Leads: Nanfang Hospital, Southern Medical University

This content was sourced from clinicaltrials.gov