Suspended

TIGERImagery as Biomarker of Imminent Transition From Asymptomatic Hyper Uricemia to Gout

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What is being tested

Dual-energy CT (DECT) and ultrasound

Other
Who is being recruted

Crystal Arthropathies+12

+ Arthritis

+ Gout

From 18 to 80 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: September 2022
See protocol details

Summary

Principal SponsorLille Catholic University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 9, 2022

Actual date on which the first participant was enrolled.

Cross-sectional studies have shown that 17% to 86% of people with apparently asymptomatic hyperuricemia have ultrasound evidence of monosodium urate (MSU) crystal deposition. These observations suggest that this deposition constitutes the first stage of the clinical gout syndrome, which has led to a revised model of disease progression and staging. However, no longitudinal studies have been undertaken to determine whether such findings are needed for the development of gout, or to investigate pathological mechanisms responsible for the transition from asymptomatic crystalline deposit to gout. Only a prospective cohort study of people at risk who are carefully and regularly followed can answer such questions. Dual-energy computed tomography (DECT) and ultrasound are the two imaging techniques that allow the visualization and quantification of MSU crystals. Ultrasound is the most widely used technique; it allows the identification of the deposit of crystals of on the surface of the cartilage (double contour sign) and of the tophi. The DECT can detect the deposition of MSU crystals in soft tissues as long as the amount of crystals exceeds the spatial resolution of the machine (about 250 μm). The international collaborative study TIGER (Transitions in gout research study) aims to address the question of the predictive value of the deposition of MSU crystals "silent" in the development of gout, through an international cohort (7 countries) including 907 asymptomatic hyperuricaemic individuals. These individuals will have initial ultrasounds to investigate the presence of MSU crystal deposits and a 5-year follow-up. Given the aforementioned ultrasound reproducibility issues, DECT analyzes will be added to the baseline assessment of TIGER participants to provide exploratory data on DECT as a potential biomarker for the impending development of gout.

Official TitleImagery as Biomarker of Imminent Transition From Asymptomatic Hyper Uricemia to Gout
NCT05434858
Principal SponsorLille Catholic University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

21 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Crystal ArthropathiesArthritisGoutJoint DiseasesMetabolic DiseasesMetabolism, Inborn ErrorsMusculoskeletal DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNutritional and Metabolic DiseasesPathologic ProcessesPurine-Pyrimidine Metabolism, Inborn ErrorsRheumatic DiseasesPathological Conditions, Signs and SymptomsGenetic Diseases, InbornHyperuricemia

Criteria

4 inclusion criteria required to participate
Serum urate level ≥ 80 mg/L on inclusion,

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.

9 exclusion criteria prevent from participating
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,

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Lille Catholic Hospital

Lille, FranceOpen Lille Catholic Hospital in Google Maps
SuspendedOne Study Center