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

NCT ID: NCT04695028

Last Updated: 2023-06-23

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-16
• Study Completion Date: 2030-10-31

Brief Summary

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.

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.

Conditions

Gout; Chondrocalcinosis; Hydroxyapatite

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Persons with crystal related arthropathies

Data collection

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lille Catholic University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tristan Pascart, MD

Role: PRINCIPAL_INVESTIGATOR

GHICL

Locations

GHICL- Hôpital Saint Philibert

Lomme, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Marie Paule LEBITASY, MD, PhD

Role: CONTACT

lebitasy.marie-paule@ghicl.net

0033320225269

William's VAN DEN BERGHE

Role: CONTACT

VanDenBerghe.Williams@ghicl.net

0033320225731

Facility Contacts

Tristan Pascart, MD

Role: primary

Other Identifiers

RC-P00101

Identifier Type: -

Identifier Source: org_study_id