Imagery as Biomarker of Gout

NCT05434858 | Active Not Recruiting

• 1 other identifier: RC-P0097
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to determine whether MSU crystal deposits visualized on ultrasound and/or DECT are associated with the development of symptomatic gout (according to ACR 2015 / EULAR criteria) over 5 years in hyperuricemic individuals.

Conditions

Hyperuricemia

Keywords

Dual-energy computed tomography; hyperuricemia; gout; monosodium urate crystals

Outcome Measures

Primary Outcomes (1)

• Odd ratios and its 95% confidence interval for the development of gout

  Development of symptomatic gout will be determined according to ACR/EULAR 2015 criteria at any time during the follow-up period. This scale is based on clinical, laboratory and imaging parameters. More than 8 points is considered as Gout. 0 is considered as absence of gout

  60 months

Secondary Outcomes (3)

• Time until development of gout symptoms

  60 months

• Odd Ratio and its 95% confidence interval for gout development according to MSU volume

  60 months

• Odd Ratio and its 95% confidence interval for comorbidities development according to MSU volume

  60 months

Study Arms (1)

Patient at high risk for gout due to elevated serum urate concentrations (≥ 8 mg/dL)

EXPERIMENTAL

Patients at high risk for gout due to elevated serum urate concentrations (≥ 8 mg/dL) will be included. The participants included will be followed for a period of 60 months, with an initial visit, a final visit as well as an additional visit in case of suspicion of gout. The presence of symptoms suggestive of gout will be evaluated during regular contact with the participants: a telephone call every 6 months as well as a postal or electronic mail every 3 months. Participants will be asked to contact the investigator if new symptoms or relevant medical events occur. Blood (32.5 ml maximum) and urine (4 ml) samples will be taken from participants who have given their specific consent for a biological collection with a particular genetic aim.

Other: Dual-energy CT (DECT) and ultrasound

Interventions

Dual-energy CT (DECT) and ultrasound OTHER

DECT and ultrasound will be performed to clarify the pathological mechanisms responsible for the transition from asymptomatic crystalline deposition to gout, and the mechanisms involved in the transition from hyperuricemia to de novo crystalline deposition.

Patient at high risk for gout due to elevated serum urate concentrations (≥ 8 mg/dL)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• No current or previous clinical symptoms of gout (including clinically apparent flares or tophus),
• Between 18 and 80 years old,
• Able to give informed consent.

You may not qualify if:

• GFR (glomerular filtration rate) \<30 ml / min / 1.73 m² or dialysis,
• Serious illness with a poor prognosis of less than 5 years,
• Autoimmune inflammatory arthritis,
• Change of geographical area within 5 years,
• Previous analysis of synovial fluid showing crystals of MSU,
• Presence of subcutaneous tophi,
• Taking a hypouricaemic treatment (allopurinol, probenecid, benzbromarone, febuxostat, lesinurad), canakinumab, anakinra or colchicine,
• Uricemia observed only after an acute decompensation of comorbidity
• Pregnant or breastfeeding women

Sponsors & Collaborators

• Lille Catholic University: lead
• Auckland University: collaborator

Study Sites (1)

Lille Catholic Hospital

Lille, Hauts-de-France, 59462, France

Location

MeSH Terms

Conditions

Hyperuricemia; Gout

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Tristan Pascart, MD, PhD

  Lille Catholic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2022
• First Posted: June 28, 2022
• Study Start: September 9, 2022
• Primary Completion: August 31, 2024
• Study Completion (Estimated): September 9, 2029
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)