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

NCT04695028 | Recruiting

• 1 other identifier: RC-P00101
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Gout; Chondrocalcinosis; Hydroxyapatite

Keywords

Gout; Chondrocalcinosis; Hydroxyapatite

Outcome Measures

Primary Outcomes (11)

• 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

Study Arms (1)

Persons with crystal related arthropathies

Other: Data collection

Interventions

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.

Persons with crystal related arthropathies

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Gout Chondrocalcinosis Hydroxyapatite

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lille Catholic University: lead

Study Sites (1)

GHICL- Hôpital Saint Philibert

Lomme, France

RECRUITING

MeSH Terms

Conditions

Gout; Chondrocalcinosis

Interventions

Data Collection

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Tristan Pascart, MD

  GHICL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie Paule LEBITASY, MD, PhD

CONTACT

0033320225269; lebitasy.marie-paule@ghicl.net

William's VAN DEN BERGHE

CONTACT

0033320225731; VanDenBerghe.Williams@ghicl.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: January 5, 2021
• Study Start: March 16, 2021
• Primary Completion: October 1, 2023
• Study Completion (Estimated): October 1, 2030
• Last Updated: June 23, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share

Locations

FR (1)