Distribution of Immune Cells and Their Subtypes in Peripheral Blood of Gout

May 5, 2024 updated by: Ai Peng
The purpose of this study is to evaluate whether immune cells and their subtypes in peripheral blood affects the asymptomatic hyperuricemia, gout flare, intercritical gout and advanced gout.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

A number of studies have reported that innate immunity cells (such as blood monocytes and neutrophils) play a crucial role in the initiation and amplification of gout flare resulted from MSU deposition in the joint or tissue, leading to release NLRP3 inflammasome-mediated production of bioactive IL-1β. Further investigation demonstrated the role of blood neutrophils might contribute to the resolution of gout flare by forming aggregated neutrophil extracellular traps. Recently, a few in vitro experiments have indicated that adaptive immunity may be involved in mechanisms of gout. However, a global understanding of blood immune responses underlying gout is still unclear. Thus, we want to investigate the relationship between immune cells and their subtypes in peripheral blood and the gout.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200272
        • Department of Nephrology & Rheumatology, Shanghai Tenth People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Asymptomatic hyperuricemia Gout flare patients Gout remission patients were classified into intercritical gout group without tophi, chronic gouty arthritis, or imaging erosion, while others were classified into advanced gout group characterized by tophi, chronic gouty arthritis, or imaging erosion.(All of these gout remission patients underwent dual-energy CT test within one month, and were detected to have MSU crystal deposition in local joints) Healthy Volunteers

Description

Inclusion Criteria:

  • gout flare:diagnosis with gout flare at this hospital according to the criteria approved by the ACR Board of Directors and the EULAR Executive Committee in 2015
  • intercritical gout: remission of gout patients were classified into intercritical gout group without tophi, chronic gouty arthritis, or imaging erosion(All of these gout remission patients underwent dual-energy CT test within one month, and were detected to have MSU crystal deposition in local joints)
  • advanced gout: gout remission patients were classified into advanced gout group characterized by tophi, chronic gouty arthritis, or imaging erosion(All of these gout remission patients underwent dual-energy CT test within one month, and were detected to have MSU crystal deposition in local joints)
  • asymptomatic hyperuricemia: hyperuricemia in men was defined as SUA ≥ 420 mmol/L without any complications

Exclusion Criteria:

  • primary osteoarticular diseases
  • unwilling participation in the study
  • corticosteroids or indomethacin use in the past 3 months;
  • septic arthritis or another joint disease (such as rheumatoid arthritis);
  • impaired renal function (creatinine clearance <30 mL/min) and other conditions which may increase the level of blood uric acid

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
NC
healthy volunteer (Normal control)：(1) aged between 18 and 80 years; (2) The serum UA levels were lower than 420 μmol/L for a man and 360 μmol/L for a woman at least one time during the two clinical tests for the samples collected with 1-week interval; (3) without any clinically diagnostic severe diseases including but not limited to a tumor, diabetes, cardiovascular, renal, nervous, digestive and mental disorders
AHU
Asymptomatic Hyperuricemia（AHU） were listed as follows: (1) aged between 18 and 80 years; (2) serum levels of UA were both greater than 420 μmol/L for a man and 360 μmol/L for a woman during the two clinical tests for the samples collected with about 1-week interval; (3) without self-reported history of the acute attack of gout; (4) without receiving medical treatment.
AGA
Acute Gout Attack (AGA) were listed as follows: (1) age between 18 and 80 years; (2) diagnosis with AG at this hospital according to the criteria approved by the ACR Board of Directors and the EULAR Executive Committee in 2015; (3) and not receiving medical treatment 3 weeks prior to the blood collection.
IG
The intercritical gout (IG) remission criteria for gout patients were listed as follows: (1) age between 18 and 80 years; (2) diagnosis with AG at this hospital according to the criteria approved by the ACR Board of Directors and the EULAR Executive Committee in 2015; (3) remission of clinical manifestations including redness, swelling, heat, and pain at local joint or bursa for at least three months since the last gout flare; (4) normal level (<8.20 mg/L) of C-reactive protein (CRP) at the time of blood collection; (5) without tophi, imaging erosion, or chronic gouty arthritis
AG
The Advanced gout (AG) criteria for gout patients were listed as follows:(1) age between 18 and 80 years; (2) diagnosis with AG at this hospital according to the criteria approved by the ACR Board of Directors and the EULAR Executive Committee in 2015; (3) remission of clinical manifestations including redness, swelling, heat, and pain at local joint or bursa for at least three months since the last gout flare; (4) normal level (<8.20 mg/L) of C-reactive protein (CRP) at the time of blood collection; (5) with tophi, imaging erosion, or chronic gouty arthritis

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
remission of gout
Time Frame: 6 month
Patients fulfilling all the domains of the 2016 preliminary remission criteria for gout were defined as gout remission group
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ai Peng

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Ai Peng, MD, PhD, Shanghai 10th People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 15, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 29, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 31, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 8, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SHSY-IEC-4.1/21-246/01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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