Kidney StonePRECILITHNCT05237063
Prediction of Recurrence and Complications of Nephrolithiasis Using a Precision Medicine Approach
A study testing Blood and urine samples in people with Kidney Stone and Nephrolithiasis, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Nephrolithiasis is a disease caused by the formation of kidney stones in the urinary tract which can then partially or completely obstruct the latter causing an extremely sharp pain called renal colic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Stone, Nephrolithiasis
- What is being tested?
- Blood and urine samples
- How many people
- 2,000 participants
- Where
- 1 siteFrance
- Study dates
- 13 Jan 2021to Feb 2031
- Phase
- Interventional
- 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
Who may be able to join
- Adults (≥18 years old), male or female ,
- Persons able to understand and object to the information provided (at the discretion of the investigator)
- Patient affiliated to social security
- Patient agreeing to sign the informed consent form
- patient having presented at least one renal colic attack before inclusion
Who cannot join
- Pregnant or breastfeeding woman.
- Persons deprived of liberty,
- Adults under legal protection guardianship, or curators or unable to express their consent.
- Patient refusing to participate in the study
- Patient in an emergency situation
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
CHU Amiens Nord
Amiens, 80054
Dominique Eladari, Pr, 06 13 03 99 01, dominique.eladari@inserm.fr
Amélie Bonnefond, DR
About this study
Nephrolithiasis is a disease caused by the formation of kidney stones in the urinary tract which can then partially or completely obstruct the latter causing an extremely sharp pain called renal colic. In industrialized countries, it affects 10 to 20% of the population, and is the most common kidney disease.The primary objective of this study is to identify the clinical, biological, genetic, molecular and environmental determinants predictive of recurrence of renal lithiasis.
The study follow-up visit schedule corresponds to the visits usually scheduled as part of patient care: 1 year from the inclusion visit (A1), 3 years (A3) then 5 years (A5). Samples for research (additional volume of blood, urine) will be taken by a registered nurse along with the routine check-up samples.Samples intended for research will be sent by staff to the Biobanque de Picardie (CHU Amiens-Picardie) for processing and conservation.
- Conditions
- Kidney Stone, Nephrolithiasis
- Being tested
- Blood and urine samples
- Keywords
- Kidney Stone, Nephrolithiasis
- Medical subject headings
- Kidney Calculi, Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood and urine samplesBiological
Additional Blood and urine samples will be collected at inclusion, 1, 3 and 5 years follow up visits
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with nephrolithiasis recurrence within 5 years of follow-up
Measured: at 5 years
Secondary outcomes (12)
Occurrence of high blood pressure patients
Measured: at 1 year
Occurrence of high blood pressure patients
Measured: at 3 years
Occurrence of high blood pressure patients
Measured: at 5 years
Occurrence of patients with diabetes
Measured: at 1 year
Occurrence of patients with diabetes
Measured: at 3 year
Occurrence of patients with diabetes
Measured: at 5 year
Occurrence of patients with osteopenia
Occurrence of patients with osteopenia during monitoring of bone mineral density with DXA
Measured: at 1 year
Occurrence of patients with osteopenia
Occurrence of patients with osteopenia during monitoring of bone mineral density with DXA
Measured: at 3 year
Occurrence of patients with osteopenia
Occurrence of patients with osteopenia during monitoring of bone mineral density with DXA
Measured: at 5 year
Occurrence of patients with a deterioration in renal function
Occurrence of patients with a deterioration in renal function during follow-up
Measured: at 1 year
Occurrence of patients with a deterioration in renal function
Occurrence of patients with a deterioration in renal function during follow-up
Measured: at 3 year
Occurrence of patients with a deterioration in renal function
Occurrence of patients with a deterioration in renal function during follow-up
Measured: at 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start13 Jan 2021
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney StoneStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Pasteur de Lille, Université de Lille
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05237063
- Sponsor's protocol ID
- PI2021_843_0137
- Acronym
- PRECILITH
- Status last verified
- Feb 2023
- First submitted
- 2 Feb 2022
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Recurrence and Complications of Nephrolithiasis Using a Precision Medicine Approach
- ClinicalTrials.gov ID
- NCT05237063
- Acronym / sponsor ID
- PRECILITH / PI2021_843_0137
- Conditions
- Kidney Stone, Nephrolithiasis
- Keywords
- Kidney Stone, Nephrolithiasis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Collaborators
- Institut Pasteur de Lille, Université de Lille
- Study start
- 13 Jan 2021 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2031 (estimated)
- First posted
- 11 Feb 2022 (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.
Nephrolithiasis is a disease caused by the formation of kidney stones in the urinary tract which can then partially or completely obstruct the latter causing an extremely sharp pain called renal colic. In industrialized countries, it affects 10 to 20% of the population, and is the most common kidney disease.The primary objective of this study is to identify the clinical, biological, genetic, molecular and environmental determinants predictive of recurrence of renal lithiasis.
The study follow-up visit schedule corresponds to the visits usually scheduled as part of patient care: 1 year from the inclusion visit (A1), 3 years (A3) then 5 years (A5). Samples for research (additional volume of blood, urine) will be taken by a registered nurse along with the routine check-up samples.Samples intended for research will be sent by staff to the Biobanque de Picardie (CHU Amiens-Picardie) for processing and conservation.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults (≥18 years old), male or female ,
- Persons able to understand and object to the information provided (at the discretion of the investigator)
- Patient affiliated to social security
- Patient agreeing to sign the informed consent form
- patient having presented at least one renal colic attack before inclusion
Key exclusion criteria (5 listed)
- Pregnant or breastfeeding woman.
- Persons deprived of liberty,
- Adults under legal protection guardianship, or curators or unable to express their consent.
- Patient refusing to participate in the study
- Patient in an emergency situation
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 |
|---|---|---|
| Blood and urine samplesAdditional Blood and urine samples will be collected at inclusion, 1, 3 and 5 years follow up visits | Biological | – |
Primary outcome
Number of patients with nephrolithiasis recurrence within 5 years of follow-up
Time frame: at 5 years
12 secondary outcomes
Occurrence of high blood pressure patients
Time frame: at 1 year
Occurrence of high blood pressure patients
Time frame: at 3 years
Occurrence of high blood pressure patients
Time frame: at 5 years
Occurrence of patients with diabetes
Time frame: at 1 year
Occurrence of patients with diabetes
Time frame: at 3 year
Occurrence of patients with diabetes
Time frame: at 5 year
Occurrence of patients with osteopenia
Time frame: at 1 year
Occurrence of patients with osteopenia
Time frame: at 3 year
Occurrence of patients with osteopenia
Time frame: at 5 year
Occurrence of patients with a deterioration in renal function
Time frame: at 1 year
Occurrence of patients with a deterioration in renal function
Time frame: at 3 year
Occurrence of patients with a deterioration in renal function
Time frame: at 5 year
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 8 Feb 2023.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood and urine samples in people with Kidney Stone and Nephrolithiasis, run by Centre Hospitalier Universitaire, Amiens 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 5 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 8 Feb 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 Dominique Eladari, Pr (06 13 03 99 01, dominique.eladari@inserm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with nephrolithiasis recurrence within 5 years of follow-up (time frame: at 5 years). 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 8 Feb 2023.