The Orienting Study (NCT07504146) | Clinical Trial Compass
RecruitingNot Applicable
The Orienting Study
Italy450 participantsStarted 2024-10-30
Plain-language summary
This study at IRCCS Galeazzi - Sant'Ambrogio Hospital involves patients with gout, CPPD, and osteoarthritis as a control group. Patients will receive routine care with regular clinical, laboratory, and imaging assessments every six months, alongside urgent visits as needed. The study aims to understand crystal deposits in joints and blood vessels and monitor their progression over time, assessing how these deposits respond to standard treatments and if they are associated with cardiovascular complications. Data will be collected from medical records over a follow-up period of up to 10 years, offering long-term insights into disease impact and treatment effectiveness.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
The inclusion criteria for CPPD patients are:
* Patients diagnosed with CPPD disease according to the ACR/EULAR 2023 classification criteria.
* Patients with evidence of asymptomatic CPPD on US or X-rays (not meeting the classification criteria) according to validated imaging definitions.
* Aged older than 18 years.
* Able to provide informed consent, according to requirements of local IRB/ethics committee.
The inclusion criteria for gout patients are:
* Patients diagnosed with gout according to the ACR/EULAR 2015 classification criteria.
* Aged older than 18 years.
* Able to provide informed consent, according to requirements of local IRB/ethics committee.
The inclusion criteria for disease controls are:
* A diagnosis of OA according to ACR classification criteria
* No evidence of uric acid or calcium pyrophosphate deposits on US
* Uric acid \< 6 mg/dL
* Aged older than 18 years.
* Able to provide informed consent, according to requirements of local IRB/ethics committee
The exclusion criteria for gout/CPPD patients are:
* Known history of other inflammatory arthropathies
* Unable to provide informed consent, according to requirements of local IRB/ethics committee.
The exclusion criteria for disease controls are:
* Known history of other inflammatory arthropathies
* Unable to provide informed consent, according to requirements of local IRB/ethics committee.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Extent of CPP crystal deposition assessed by ultrasound over time
Timeframe: Baseline and every 6 months up to 10 years
2
Extent of MSU crystal deposition assessed by ultrasound over time
Timeframe: Baseline and every 6 months up to 10 years
3
Progression of bone erosions assessed by ultrasound
Timeframe: Baseline and every 6 months up to 10 years
4
Progression of osteophites assessed by ultrasound
Timeframe: Baseline and every 6 months up to 10 years