Bidirectional Cohort Study of Nanfang Spondyloarthritis

NCT ID: NCT06988813

Last Updated: 2025-05-25

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 3000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-05-17
• Study Completion Date: 2030-04-30

Brief 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.

Detailed Description

In this study, on the basis of not imposing randomized or interventional treatments and not generating additional examination tests on patients, the chronic disease data formed by multiple visits of SpA patients using conventional treatment regimens were used to form a bi-directional, disease-specific cohort by means of data entry alone, consisting of: one SpA condition information dataset, one SpA imaging dataset.

SpA condition information dataset: enter the disease duration, symptom characteristics, family history, comorbidities, previous medication use and efficacy of all outpatient diagnosed SpA patients; for each natural visit time point, establish BASDAI and ASDASCRP scores to assess the disease activity, assess the patient's physical functioning by BASFI scale, and EQ-5D and SF-36 scales to assess the quality of life; Recorded labs for each visit such as CRP, ESR and anti-streptococcal hemolysin O (ASO), anti-streptococcal DNAase B (ADNS). The subject group will not direct patients to lab tests that are not prescribed by the attending physician.

SpA imaging dataset: all imaging data of patients diagnosed with SpA and naturally attending our clinic were recorded, including: MRI of sacroiliac joints, MRI of hips, MRI of cervical/lumbar/thoracic spine, and orthopantomogram of pelvis, CT of sacroiliac joints, or vascular ultrasound of sacroiliac joints and lower limbs, and the imaging data were archived after preliminary SPARCC and SPARCC SSS scores were made. The subject group would not direct patients to examinations that were not prescribed by the attending physician.

Conditions

Spondyloarthritis (SpA); Ankylosing Spondylitis (AS)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 1. Women who are pregnant, preparing for pregnancy or breastfeeding 2.Moderate to Severe Heart Failure (New York Heart Association Class 3-4) 3.Active peptic ulcers/bleeding 4.Judged by the investigator to be unsuitable for participation in this study

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Southern Medical University, China

OTHER

Sponsor Role: collaborator

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nanfang Hostipal,Southern Medical University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jun Xiao, Dr

Role: CONTACT

orthopaedxj@163.com

0086-20-18665000156

Facility Contacts

Jun Xiao, Dr

Role: primary

orthopaedxj@163.com

0086-20-18665000156

Other Identifiers

NFEC-2025-228

Identifier Type: -

Identifier Source: org_study_id