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Imagery as Biomarker of Gout (TIGER)

Primary Purpose

Hyperuricemia

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Dual-energy CT (DECT) and ultrasound
Sponsored by
Lille Catholic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hyperuricemia focused on measuring Dual-energy computed tomography, hyperuricemia, gout, monosodium urate crystals

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Sites / Locations

  • Lille Catholic HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Time until development of gout symptoms
Time from initial visit to onset of symptomatic gout
Odd Ratio and its 95% confidence interval for gout development according to MSU volume
Odd Ratio and its 95% confidence interval for comorbidities development according to MSU volume

Full Information

First Posted
June 14, 2022
Last Updated
November 28, 2022
Sponsor
Lille Catholic University
Collaborators
Auckland University
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1. Study Identification

Unique Protocol Identification Number
NCT05434858
Brief Title
Imagery as Biomarker of Gout
Acronym
TIGER
Official Title
Imagery as Biomarker of Imminent Transition From Asymptomatic Hyper Uricemia to Gout
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 9, 2022 (Actual)
Primary Completion Date
September 9, 2024 (Anticipated)
Study Completion Date
September 9, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lille Catholic University
Collaborators
Auckland University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperuricemia
Keywords
Dual-energy computed tomography, hyperuricemia, gout, monosodium urate crystals

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patient at high risk for gout due to elevated serum urate concentrations (≥ 8 mg/dL)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Dual-energy CT (DECT) and ultrasound
Intervention Description
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.
Primary Outcome Measure Information:
Title
Odd ratios and its 95% confidence interval for the development of gout
Description
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
Time Frame
60 months
Secondary Outcome Measure Information:
Title
Time until development of gout symptoms
Description
Time from initial visit to onset of symptomatic gout
Time Frame
60 months
Title
Odd Ratio and its 95% confidence interval for gout development according to MSU volume
Time Frame
60 months
Title
Odd Ratio and its 95% confidence interval for comorbidities development according to MSU volume
Time Frame
60 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marie Desolere
Phone
+33320225931
Email
desolere.marie@ghicl.net
First Name & Middle Initial & Last Name or Official Title & Degree
Elodie Moutailler, CRA
Phone
+33320225701
Ext
+33
Email
moutailler.elodie@ghicl.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tristan Pascart, MD, PhD
Organizational Affiliation
Lille Catholic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lille Catholic Hospital
City
Lille
State/Province
Nord Pas De Calais
ZIP/Postal Code
59462
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie Paule LEBITASY
Phone
03 20 22 52 69
Ext
+33
Email
lebitasy.marie-paule@ghicl.net
First Name & Middle Initial & Last Name & Degree
Elodie MOUTAILLER
Phone
03 20 22 52 69
Ext
+33
Email
moutailler.elodie@ghicl.net
First Name & Middle Initial & Last Name & Degree
Tristan PASCART, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Imagery as Biomarker of Gout

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