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Clinical application of HFREP1 serum protein test kit in rheumatoid arthritis disease evaluation and precision diagnosis and treatment

Study on the clinical application performance and effectiveness of HFREP1 protein detection kit in assisting the diagnosis of rheumatoid arthritis

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400082686
Enrollment
Unknown
Registered
2024-04-03
Start date
2023-05-05
Completion date
Unknown
Last updated
2024-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

rheumatoid arthritis, RA

Interventions

Gold Standard:Meet the 1987 American College of Rheumatology classification criteria or the 2010 American College of Rheumatology/European League Against Rheumatism classification criteria.
Index test:HFREP1 protein

Sponsors

Zhongda Hospital Southeast University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Those who fulfill all of the following criteria are eligible for enrollment: RA population: ? 18-75 years of age (including borderline values) and gender; ? All meet the 1987 American College of Rheumatology classification criteria or the 2010 American College of Rheumatology/European League Against Rheumatism classification criteria; ? Voluntarily participated in the study and signed a written informed consent. Non-RA population: ? 18-75 years of age (including borderline values) and gender; ? Not meeting the 1987 American College of Rheumatology classification criteria or the 2010 American College of Rheumatology/European League Against Rheumatism classification criteria; ?Voluntarily participated in this study and signed a written informed consent.

Exclusion criteria

Exclusion criteria: Exclusion was required if any of the following criteria were met: ? Patients who have participated in a non-interventional clinical trial within 3 months prior to screening; ? Those with a history of any of the following diseases: a. Those with a history of malignancy; b. Those with a history of hepatitis B or C; c. Those with a history of acute infections within 1 month prior to screening: e.g., colds, fevers, new crown infections, pneumonia, etc.; d. Those with a history of chronic inflammatory diseases: e.g., nephritis, pancreatitis, etc.; e. Those with a history of diabetes. ? Other conditions that the investigator considers unsuitable for enrollment.

Design outcomes

Primary

MeasureTime frame
Rheumatoid Factor(RF);anti-cyclic peptide containing citrulline(CCP);

Secondary

MeasureTime frame
Erythrocyte Sedimentation Rate(ESR);C reactive protein(CRP);

Countries

China

Contacts

Public ContactXiaoyan Xu Huixia Lu

Zhongda Hospital Southeast University

njxxy111@qq.com+86 139 1385 9516

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026