GoutCRYSTALILLENCT04695028
CRYSTALILLE Cohort: Getting the Whole Picture of Crystal-related Arthropathies
An observational study of Gout and Chondrocalcinosis, run by Lille Catholic University at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gout, Chondrocalcinosis, Hydroxyapatite
- What is being tested?
- Data collection
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 16 Mar 2021to Oct 2030
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Gout Chondrocalcinosis Hydroxyapatite
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
GHICL- Hôpital Saint Philibert
Lomme
Tristan Pascart, MD
Tristan Pascart
About this study
Official title: Data Collection for the Constitution of an Observatory for Patients Suffering From Microcrystalline Rheumatism With Morphological Phenotyping
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.
Read the 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.
- Conditions
- Gout, Chondrocalcinosis, Hydroxyapatite
- Being tested
- Data collection
- Keywords
- Gout, Chondrocalcinosis, Hydroxyapatite
- Medical subject headings
- Gout, Chondrocalcinosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Persons with crystal related arthropathies | Not described Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of microcrystalline rheumatism
Measured: day 0
Weight
measured in Kg
Measured: day 0
Height
measured in cm
Measured: day 0
Index body mass
Measured: day 0
Comorbidities
Measured: day 0
Number of rheumatic flares
Measured: day 0
Intensity of rheumatic flares
Measured: day 0
Identification of subcutaneous tophi
Measured: day 0
Uricemia
Measured: 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
Measured: day 0
Lipid profile
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start16 Mar 2021
- Primary completionOct 2023 (estimated)
- Study completionOct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GoutStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tristan Pascart, MD, Principal investigator, GHICL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04695028
- Sponsor's protocol ID
- RC-P00101
- Acronym
- CRYSTALILLE
- Status last verified
- Jun 2023
- First submitted
- 16 Dec 2020
- Last updated
- 23 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Data Collection for the Constitution of an Observatory for Patients Suffering From Microcrystalline Rheumatism With Morphological Phenotyping
- ClinicalTrials.gov ID
- NCT04695028
- Acronym / sponsor ID
- CRYSTALILLE / RC-P00101
- Conditions
- Gout, Chondrocalcinosis, Hydroxyapatite
- Keywords
- Gout, Chondrocalcinosis, Hydroxyapatite
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Study start
- 16 Mar 2021 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2030 (estimated)
- First posted
- 5 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Persons with crystal related arthropathies | – | Other: Data collection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Gout Chondrocalcinosis Hydroxyapatite
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collectionThe 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. | Other | Persons with crystal related arthropathies |
Primary outcome
Diagnosis of microcrystalline rheumatism
Time frame: day 0
Weight
Time frame: day 0
measured in Kg
Height
Time frame: day 0
measured in cm
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
Panel includes albumin, calcium, carbon dioxide, creatinine, chloride, glucose, phosphorous, potassium, sodium, and BUN and a calculated anion gap value
Lipid profile
Time frame: day 0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2023.
- Individual participant dataSharing planned: Yes
Related trials for Gout
RecruitingPhase 4
Treat-to-Target Serum Urate Versus Treat-to-Avoid Symptoms in Gout
Gout
RecruitingPhase 3
A Study of Dotinurad Versus Allopurinol in Participants With Gout
Gout
RecruitingPhase 3
A Study of Dotinurad Versus Allopurinol in Tophaceous Gout
Tophaceous Gout
Not yet recruitingPhase 3
Combined Metabolic Activator Supplementation in Subjects Diagnosed With Gout
Gout Disease
Enrolling by invitation
The Remote Monitoring of Gout Study
Gout Initiating Urate-loweringUrate-lowering Therapy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tristan Pascart, MD principal investigator
GHICL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gout and Chondrocalcinosis, run by Lille Catholic University at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie Paule LEBITASY, MD, PhD (0033320225269, lebitasy.marie-paule@ghicl.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of microcrystalline rheumatism (time frame: day 0). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2023.