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NCT Number: NCT04695028

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

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.

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Key information

Conditions

Gout Arthritis Chondrocalcinosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Crystal Arthropathies Genetic Diseases, Inborn Hydroxyapatite Joint Diseases Metabolic Diseases Metabolism, Inborn Errors Musculoskeletal Diseases Nutritional and Metabolic Diseases Purine-Pyrimidine Metabolism, Inborn Errors Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

GHICL- Hôpital Saint Philibert

Lomme, France

Location status: Recruiting

Location contact

Tristan Pascart

PRINCIPAL_INVESTIGATOR

Tristan Pascart, MD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Data Collection

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.

Primary outcomes

  1. Diagnosis of microcrystalline rheumatism

    Time frame: day 0

  2. Weight

    Time frame: day 0

    measured in Kg

  3. Height

    Time frame: day 0

    measured in cm

  4. Index body mass

    Time frame: day 0

  5. Comorbidities

    Time frame: day 0

  6. Number of rheumatic flares

    Time frame: day 0

  7. Intensity of rheumatic flares

    Time frame: day 0

  8. Identification of subcutaneous tophi

    Time frame: day 0

  9. Uricemia

    Time frame: day 0

  10. Renal function panel

    Time frame: day 0

    Panel includes albumin, calcium, carbon dioxide, creatinine, chloride, glucose, phosphorous, potassium, sodium, and BUN and a calculated anion gap value

  11. Lipid profile

    Time frame: day 0

Study contacts

Contact information is provided by the study sponsor or research team.

Marie Paule LEBITASY, MD, PhD

CONTACT

[email protected]

0033320225269

William's VAN DEN BERGHE

CONTACT

[email protected]

0033320225731

Sponsors and collaborators

Lead sponsor

Lille Catholic University

Other

Registry information

Official study title

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

Acronym: CRYSTALILLE

Important dates

Study start
2021
Primary completion
2023
Study completion
2030
First posted
Jan 5, 2021
Registry last updated
Jun 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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