Screening for Biomarkers of Osteoarthritis

NCT07544823 | Recruiting DMC

• 1 other identifier: OA-XXMU-20260201
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Osteoarthritis (OA) is the most prevalent degenerative joint disease worldwide, which causes pain, loss of joint function and declined quality of life, and ranks as the leading cause of disability among individuals aged over 60 years. In China, the number of patients with osteoarthritis is projected to exceed 200 million by 2044, resulting in a continuously growing demand for medical resources and escalating economic burden.Nevertheless, the lack of effective biomarkers for early diagnosis leads to advanced disease conditions at the time of initial medical consultation and delayed treatment. This project intends to collect blood samples from OA patients and suspected patients in the orthopedic outpatient department of a tertiary hospital. Diagnostic and differential diagnostic tests will be adopted to verify the clinical application value of previously reported candidate biomarkers, so as to screen out biomarkers with favorable validity and reliability. The research findings are expected to provide data support and theoretical basis for the early prevention, early diagnosis and individualized intervention of osteoarthritis.

Conditions

Osteoarthritis (OA)

Keywords

Osteoarthritis; Biomarker

Outcome Measures

Primary Outcomes (2)

• Diagonse of OA

  Disease diagnosis was made in accordance with the osteoarthritis diagnostic criteria established by the American College of Rheumatology (ACR).

  at enrollment

• Screening biomarkers for OA

  Screen blood biomarkers available for the early diagnosis of osteoarthritis.

  About 100 days after all sample collected.

Study Arms (1)

Patients with suspected osteoarthritis

The study subjects shall include patients with osteoarthritis (OA) at different anatomical sites as far as possible, such as the knee, hip and hand. Enrollment will focus on early-stage OA patients with Kellgren-Lawrence (K-L) grade 1-2. Meanwhile, patients with diseases that share similar clinical manifestations with OA and are prone to misdiagnosis shall also be enrolled.

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study subjects shall include patients with osteoarthritis (OA) at different anatomical sites as far as possible, such as the knee, hip and hand. Enrollment will focus on early-stage OA patients with Kellgren-Lawrence (K-L) grade 1-2. Meanwhile, patients with diseases that share similar clinical manifestations with OA and are prone to misdiagnosis shall also be enrolled.

You may qualify if:

• Aged between 40 and 70 years (inclusive);
• Joint pain or stiffness lasting for no less than 3 months;
• Voluntary participation with signed informed consent.

You may not qualify if:

• Combined with other severe joint diseases, such as rheumatoid arthritis, gout, etc.;
• Suffering from severe systemic diseases, such as heart failure, malignant tumors and others;
• Received joint surgery within the past 3 months or taking medications that may affect the progression of osteoarthritis;
• Individuals with cognitive dysfunction who are unable to cooperate with the research procedures;
• Failure to complete X-ray, MRI examination or follow-up visits as required.

Sponsors & Collaborators

• The First Affiliated Hospital of Xinxiang Medical College: lead

Study Sites (1)

The First Affiliated Hospital of Henan Medical University

Xinxiang, Henan, 453003, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

serum and pellet

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Wenjie Ren

  The First Affiliated Hospital of Henan Medical University

  STUDY CHAIR

Central Study Contacts

Wenjie Ren

CONTACT

8618937302619; 157121431@qq.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: April 22, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

CN (1)