Osteoarthritis (OA)NCT07544823
Screening for Biomarkers of Osteoarthritis
An observational study of Osteoarthritis (OA), run by The First Affiliated Hospital of Xinxiang Medical College at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Osteoarthritis (OA)
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2026to 30 Dec 2026
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Aged between 40 and 70 years (inclusive);
- Joint pain or stiffness lasting for no less than 3 months;
- Voluntary participation with signed informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Henan Medical University
Xinxiang, Henan, 453003
Tan Lu, 8613663901294, Lutan1982@163.com
About this study
Official title: Screening of Biomarkers for Osteoarthritis and Establishment of a Multidimensional Data Based Early Diagnostic Method
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.
Read the detailed description
Osteoarthritis (OA), the most common degenerative joint disease worldwide, is witnessing an increasingly severe epidemiological trend in China driven by population aging and shifts in lifestyle. According to the Global Burden of Disease (GBD) data, the number of OA patients in China has risen from 26.1 million in 1990 to 61.2 million in 2019, ranking first globally, and is projected to exceed 200 million by 2044. The prevalence of OA increases markedly with age, affecting over 50% of individuals aged 65 years and older. Women exhibit a higher incidence than men, especially after menopause, and tend to suffer from more severe structural lesions and clinical symptoms. The knee joint is the most frequently affected site, followed by the hands, hips and other joints.
OA not only causes pain, loss of joint function and impaired quality of life, but also represents the leading cause of disability in the population aged over 60. In 2019, the age-standardized disability-adjusted life years (DALYs) of OA in China reached 224.78 per 100,000 population, a 9.4% increase compared with 1990. Notably, the disease burden of knee and hip OA related to elevated body mass index (BMI) has increased substantially in males, and the growth rate of DALYs attributable to high BMI is higher for hip OA than for knee OA. Meanwhile, the disease burden of hand OA is also on the rise among females.
Major risk factors for OA include advanced age, obesity, joint injury and occupational strain such as sedentary behavior and repetitive weight-bearing activities. Since the reform and opening-up, China has achieved rapid economic development and a remarkable extension in life expectancy. By the end of 2024, the population aged 65 and above had reached 220 million, accounting for 15.6% of the total population; life expectancy is expected to reach 81.3 years by 2035. In parallel, behavioral risk factors closely linked to OA, including a sedentary lifestyle, insufficient physical activity, unhealthy dietary patterns, elevated BMI, smoking and alcohol consumption, have become increasingly prevalent. Under the combined effect of population aging and unhealthy lifestyles, the incidence, prevalence and overall disease burden of OA are predicted to climb continuously. This places a heavy burden on the healthcare system and poses a major challenge to the achievement of the Healthy China Initiative.
Current clinical management of OA is confronted with two core bottlenecks. First, there is a scarcity of early diagnostic biomarkers and individualized prediction tools. Most patients seek medical care only after obvious symptoms emerge, by which time irreversible structural damage to joints has already developed. Second, OA is a highly heterogeneous disease. The pathogenesis of OA at different anatomical sites (knee, hip, hand, etc.) involves the complex interaction of multiple factors including mechanical overload, low-grade inflammation and metabolic disorders. Consequently, there are currently no effective therapies capable of reversing disease progression, and clinical interventions remain limited to symptomatic relief.
Accordingly, the establishment of a specialized OA cohort is of critical importance. By systematically collecting high-risk factors, clinical phenotypes, imaging findings, biological specimens (blood, synovial fluid, joint tissue, etc.) and multi-omics data, the specialized cohort will facilitate precision prevention and treatment of OA in the following aspects: 1. Identification of novel biomarkers for early diagnosis and prognostic evaluation; 2. Construction of artificial intelligence-assisted individualized diagnosis and prediction models, which integrate multidimensional data to realize early disease warning, progression risk stratification and treatment response prediction.
- Conditions
- Osteoarthritis (OA)
- Keywords
- Osteoarthritis, Biomarker
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagonse of OA
Disease diagnosis was made in accordance with the osteoarthritis diagnostic criteria established by the American College of Rheumatology (ACR).
Measured: at enrollment
Screening biomarkers for OA
Screen blood biomarkers available for the early diagnosis of osteoarthritis.
Measured: About 100 days after all sample collected.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start20 Apr 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis (OA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Xinxiang Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wenjie Ren, Study chair, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07544823
- Sponsor's protocol ID
- OA-XXMU-20260201
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening of Biomarkers for Osteoarthritis and Establishment of a Multidimensional Data Based Early Diagnostic Method
- ClinicalTrials.gov ID
- NCT07544823
- Acronym / sponsor ID
- OA-XXMU-20260201
- Conditions
- Osteoarthritis (OA)
- Keywords
- Osteoarthritis, Biomarker
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Xinxiang Medical CollegeUniversity, hospital or other
- Study start
- 20 Apr 2026 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 22 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Osteoarthritis (OA), the most common degenerative joint disease worldwide, is witnessing an increasingly severe epidemiological trend in China driven by population aging and shifts in lifestyle. According to the Global Burden of Disease (GBD) data, the number of OA patients in China has risen from 26.1 million in 1990 to 61.2 million in 2019, ranking first globally, and is projected to exceed 200 million by 2044. The prevalence of OA increases markedly with age, affecting over 50% of individuals aged 65 years and older. Women exhibit a higher incidence than men, especially after menopause, and tend to suffer from more severe structural lesions and clinical symptoms. The knee joint is the most frequently affected site, followed by the hands, hips and other joints.
OA not only causes pain, loss of joint function and impaired quality of life, but also represents the leading cause of disability in the population aged over 60. In 2019, the age-standardized disability-adjusted life years (DALYs) of OA in China reached 224.78 per 100,000 population, a 9.4% increase compared with 1990. Notably, the disease burden of knee and hip OA related to elevated body mass index (BMI) has increased substantially in males, and the growth rate of DALYs attributable to high BMI is higher for hip OA than for knee OA. Meanwhile, the disease burden of hand OA is also on the rise among females.
Major risk factors for OA include advanced age, obesity, joint injury and occupational strain such as sedentary behavior and repetitive weight-bearing activities. Since the reform and opening-up, China has achieved rapid economic development and a remarkable extension in life expectancy. By the end of 2024, the population aged 65 and above had reached 220 million, accounting for 15.6% of the total population; life expectancy is expected to reach 81.3 years by 2035. In parallel, behavioral risk factors closely linked to OA, including a sedentary lifestyle, insufficient physical activity, unhealthy dietary patterns, elevated BMI, smoking and alcohol consumption, have become increasingly prevalent. Under the combined effect of population aging and unhealthy lifestyles, the incidence, prevalence and overall disease burden of OA are predicted to climb continuously. This places a heavy burden on the healthcare system and poses a major challenge to the achievement of the Healthy China Initiative.
Current clinical management of OA is confronted with two core bottlenecks. First, there is a scarcity of early diagnostic biomarkers and individualized prediction tools. Most patients seek medical care only after obvious symptoms emerge, by which time irreversible structural damage to joints has already developed. Second, OA is a highly heterogeneous disease. The pathogenesis of OA at different anatomical sites (knee, hip, hand, etc.) involves the complex interaction of multiple factors including mechanical overload, low-grade inflammation and metabolic disorders. Consequently, there are currently no effective therapies capable of reversing disease progression, and clinical interventions remain limited to symptomatic relief.
Accordingly, the establishment of a specialized OA cohort is of critical importance. By systematically collecting high-risk factors, clinical phenotypes, imaging findings, biological specimens (blood, synovial fluid, joint tissue, etc.) and multi-omics data, the specialized cohort will facilitate precision prevention and treatment of OA in the following aspects: 1. Identification of novel biomarkers for early diagnosis and prognostic evaluation; 2. Construction of artificial intelligence-assisted individualized diagnosis and prediction models, which integrate multidimensional data to realize early disease warning, progression risk stratification and treatment response prediction.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Aged between 40 and 70 years (inclusive);
- Joint pain or stiffness lasting for no less than 3 months;
- Voluntary participation with signed informed consent.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagonse of OA
Time frame: at enrollment
Disease diagnosis was made in accordance with the osteoarthritis diagnostic criteria established by the American College of Rheumatology (ACR).
Screening biomarkers for OA
Time frame: About 100 days after all sample collected.
Screen blood biomarkers available for the early diagnosis of osteoarthritis.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Osteoarthritis (OA)
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The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wenjie Ren study chair
The First Affiliated Hospital of Zhengzhou University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis (OA), run by The First Affiliated Hospital of Xinxiang Medical College at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenjie Ren (8618937302619, 157121431@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagonse of OA (time frame: at enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.