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

Sponsor
Lille Catholic University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04695028
Collaborator
(none)
1,000
117

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
1000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Data Collection for the Constitution of an Observatory for Patients Suffering From Microcrystalline Rheumatism With Morphological Phenotyping
Anticipated Study Start Date :
Jan 1, 2021
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Oct 1, 2030

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Diagnosis of microcrystalline rheumatism [day 0]

  2. Weight [day 0]

    measured in Kg

  3. Height [day 0]

    measured in cm

  4. Index body mass [day 0]

  5. Comorbidities [day 0]

  6. Number of rheumatic flares [day 0]

  7. Intensity of rheumatic flares [day 0]

  8. Identification of subcutaneous tophi [day 0]

  9. Uricemia [day 0]

  10. Renal function panel [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 [day 0]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Lille Catholic University

Investigators

  • Principal Investigator: Tristan Pascart, GHICL

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lille Catholic University
ClinicalTrials.gov Identifier:
NCT04695028
Other Study ID Numbers:
  • RC-P00101
First Posted:
Jan 5, 2021
Last Update Posted:
Jan 5, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Lille Catholic University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 5, 2021