CRYSTALILLE Cohort: Getting the Whole Picture of Crystal-related Arthropathies (CRYSTALILLE)

Data Collection for the Constitution of an Observatory for Patients Suffering From Microcrystalline Rheumatism With Morphological Phenotyping

The objective of this research is to collect data to create an observatory of microcrystalline rheumatism (gout and calcium-crystal rheumatism) in patients treated at the Groupement des Hôpitaux de l'Institut Catholique de Lille, in order to better understand the disease and improve patient care, in particular with the help of medical imaging.

Study Overview

• Status: Recruiting
• Conditions: Gout; Chondrocalcinosis; Hydroxyapatite
• Intervention / Treatment: Other: Data collection

Detailed Description

All patients already included in another observational study set up in 2016 and meeting the eligibility criteria may be included in this study. An information letter will be sent to them by mail. If they wish to oppose to the use of their data, they can then return the objection form.

This sample will be supplemented by new patients who are recruited during a classic rheumatology consultation. The investigator will propose the study to all patients meeting the inclusion and non-inclusion criteria.

They will be informed of the objectives of the study and their rights. For patients who agree to participate in the study, sociodemographic and clinical characteristics will be collected.

Depending on the usual care, they will benefit from an ultrasound and/or a dual energy scanner (M0). Imaging data will be collected. Routine clinical follow-up is then carried out in consultation, with collection of clinical and biological evolution data, and morphological data if necessary if imaging is rechecked, until the patient is lost to follow-up or the follow-up is interrupted at the GHICL for any reason.

Available quarterly or semi-annual data will be collected.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Marie Paule LEBITASY, MD, PhD; Phone Number: 0033320225269; Email: lebitasy.marie-paule@ghicl.net
• Study Contact Backup: Name: William's VAN DEN BERGHE; Phone Number: 0033320225731; Email: VanDenBerghe.Williams@ghicl.net

Study Locations

• France
  • Lomme, France
    • Recruiting
    • GHICL- Hôpital Saint Philibert
    • Contact: Tristan Pascart, MD
    • Principal Investigator: Tristan Pascart

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Gout Chondrocalcinosis Hydroxyapatite

Description

Inclusion Criteria:

• Diagnosis of gout according to American College of Rheumatology /European League Against Rheumatism (ACR/EULAR) 2015 criteria OR diagnosis of calcium pyrophosphate dihydrate crystal deposition disease (CPPD) based on EULAR 2011 recommendations OR diagnosis of hydroxyapatite crystal rheumatism (HCR) according to a typical clinical sequence and demonstration of compatible calcium deposits on imaging
• patient who will benefit or has benefited from an ultrasound and/or DECT evaluation of microcrystalline deposits
• clinical suspicion of microcrystalline rheumatism requiring further imaging to confirm the diagnosis

Exclusion Criteria:

• Refusal or contra-indication to perform ultrasound or dual energy scanning.
• Patient's opposition to the use of his or her health data for research purposes
• Patient under guardianship or curatorship
• Pregnant woman
• Person not affiliated to a social security scheme or entitled to a social security benefit

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Persons with crystal related arthropathies

Other: Data collection; The following data will be collected by the physician: sociodemographic profile, clinical manifestations, comorbidities, laboratory tests,etc. Diagnostic performance of different imagery techniques, performance of crystal deposit quantification in ultrasound and Dual-energy computed tomography (DECT), link between co-morbidities and volume of baseline crystal deposits then during monitoring, link between co-morbidities (including cardiovascular events and new diagnoses of co-morbidity) and vascular baseline crystal deposits and during follow-up, link between microcrystalline rheumatism activity and the quantity of crystal deposits in baseline imaging and during follow-up, link between co-morbidities and the evolution of microcrystalline baseline rheumatism and then during follow-up, link between co-morbidities and the evolution of crystal deposition volumes, the concordance of the evaluation of uratic stocks and their evolution between the imagery means.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnosis of microcrystalline rheumatism		day 0
Weight	measured in Kg	day 0
Height	measured in cm	day 0
Index body mass		day 0
Comorbidities		day 0
Number of rheumatic flares		day 0
Intensity of rheumatic flares		day 0
Identification of subcutaneous tophi		day 0
Uricemia		day 0
Renal function panel	Panel includes albumin, calcium, carbon dioxide, creatinine, chloride, glucose, phosphorous, potassium, sodium, and BUN and a calculated anion gap value	day 0
Lipid profile		day 0

Collaborators and Investigators

• Sponsor: Lille Catholic University
• Investigators: Principal Investigator: Tristan Pascart, MD, GHICL

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2021
• Primary Completion (Estimated): October 1, 2023
• Study Completion (Estimated): October 1, 2030

Study Registration Dates

• First Submitted: December 16, 2020
• First Submitted That Met QC Criteria: January 4, 2021
• First Posted (Actual): January 5, 2021

Study Record Updates

• Last Update Posted (Actual): June 23, 2023
• Last Update Submitted That Met QC Criteria: June 21, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Gout; Hydroxyapatite; Chondrocalcinosis
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis; Crystal Arthropathies; Chondrocalcinosis
• Other Study ID Numbers: RC-P00101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No