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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04695028
Recruitment Status : Not yet recruiting
First Posted : January 5, 2021
Last Update Posted : January 5, 2021
Sponsor:
Information provided by (Responsible Party):
Lille Catholic University

Study Description
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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
Gout Chondrocalcinosis Hydroxyapatite 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
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Data Collection for the Constitution of an Observatory for Patients Suffering From Microcrystalline Rheumatism With Morphological Phenotyping
Estimated Study Start Date : January 2021
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2030

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Gout
MedlinePlus related topics: Gout

Groups and Cohorts
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Group/Cohort 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
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Primary Outcome Measures :
  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 ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Gout Chondrocalcinosis Hydroxyapatite
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04695028


Contacts
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Contact: Amélie Lansiaux, MD, PhD 0033320225269 lansiaux.amelie@ghicl.net
Contact: Mélanie Hamez 0033320225731 hamez.melanie@ghicl.net

Sponsors and Collaborators
Lille Catholic University
Investigators
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Principal Investigator: Tristan Pascart GHICL
More Information
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Responsible Party: Lille Catholic University
ClinicalTrials.gov Identifier: NCT04695028    
Other Study ID Numbers: RC-P00101
First Posted: January 5, 2021    Key Record Dates
Last Update Posted: January 5, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lille Catholic University:
Gout
Chondrocalcinosis
Hydroxyapatite
Additional relevant MeSH terms:
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Chondrocalcinosis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Crystal Arthropathies