NCT05065606

Brief Summary

The main objective is to describe urate deposits (especially in terms of distribution and volume) in soft tissues and bone, and joint erosions and destruction, in adult patients with gout.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2016

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 30, 2016

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

November 19, 2020

Completed
11 months until next milestone

First Posted

Study publicly available on registry

October 4, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
Last Updated

October 4, 2021

Status Verified

September 1, 2021

Enrollment Period

5 years

First QC Date

November 19, 2020

Last Update Submit

September 22, 2021

Conditions

Gout

Outcome Measures

Primary Outcomes (3)

  • Soft tissue tophus description

    Description of soft tissue tophus in terms of location, size, density at high and low energy

    The day of the CT (computed tomography) examination

  • Distribution of urate deposits

    Distribution of urate deposits in soft tissues and bone, and joint erosions and destruction

    The day of the CT examination

  • Descriptive analysis of joint erosions and destruction

    Descrition of joint erosions and destruction :erosion size (mm) and location (joint), joint destruction (space narrowing, joint collapse, joint ankylosis).

    The day of the CT examination

Secondary Outcomes (6)

  • Correlation of the descriptive parameters on dual-energy CT with clinical data

    The day of the CT examination

  • Variations in tophaceous burden

    The day of the CT examination

  • Link between tophus and erosions

    The day of the CT examination

  • Reproducibility of a scoring system

    The day of the CT examination

  • Bone mineral density

    The day of the CT examination

  • +1 more secondary outcomes

Interventions

Dual-energy computed tomographyDIAGNOSTIC_TEST

Dual-energy scanner examinations stored in the PACS (medical imagery) at Lariboisière Hospital are to be analyzed retrospectively and prospectively

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Retrospective analysis of dual-energy CT exams performed in routine care in patients with gout according to ACR criteria, patients included between end of year 2016 and end of year 2021 (retrospective and prospective inclusion, retrospective analysis)

You may qualify if:

  • Age greater than or equal to 18 years old;
  • Patient with a gout according to ACR (American College of Rheumatology) criteria;
  • Affiliated with a social security scheme.
  • Dual-energy scanner examinations stored in the PACS at Lariboisière Hospital

You may not qualify if:

  • Pregnant or breastfeeding woman.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hôpital Lariboisière - Service d'Imagerie OstéoArticulaire, Viscérale et Vasculaire

Paris, 75010, France

RECRUITING

Hôpital Lariboisière - Service de Rhumatologie

Paris, 75010, France

RECRUITING

Hôpital Bichat - Service de Rhumatologie

Paris, 75018, France

RECRUITING

MeSH Terms

Conditions

Gout

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesCrystal ArthropathiesRheumatic DiseasesPurine-Pyrimidine Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Valérie BOUSSON, PUPH

    APHP Lariboisière - Imagerie OstéoArticulaire,Viscérale

    STUDY DIRECTOR

  • Valérie BOUSSON, PUPH

    APHP Lariboisière - Imagerie OstéoArticulaire,Viscérale

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Valérie BOUSSON, PUPH

CONTACT

+33(0)149959107valerie.bousson@aphp.fr

Valérie BOUSSON, PUPH

CONTACT

+33(0)149959106valerie.bousson@aphp.fr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2020

First Posted

October 4, 2021

Study Start

November 30, 2016

Primary Completion

November 30, 2021

Study Completion

November 30, 2021

Last Updated

October 4, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(3)