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Recruiting NCT04695028

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

— Observational Gout Chondrocalcinosis Hydroxyapatite

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Data collection.
Who it may be relevant to
Registry conditions: Gout, Chondrocalcinosis, Hydroxyapatite. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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 vasc

Primary outcome measures

  • Diagnosis of microcrystalline rheumatism [Time frame: day 0]
  • Weight [Time frame: day 0]
  • Height [Time frame: day 0]
  • Index body mass [Time frame: day 0]
  • Comorbidities [Time frame: day 0]
  • Number of rheumatic flares [Time frame: day 0]
  • Intensity of rheumatic flares [Time frame: day 0]
  • Identification of subcutaneous tophi [Time frame: day 0]
  • Uricemia [Time frame: day 0]
  • Renal function panel [Time frame: day 0]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • GHICL- Hôpital Saint Philibert — Lomme

Identifiers

NCT: NCT04695028 · RC-P00101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗