Tuberous Sclerosis ComplexTSARNCT02887781
Clinical Presentation and Renal Outcome of Patients With Tuberous Sclerosis Complex and/or Renal Angiomyolipoma in the Great West Region of France
An observational study of Tuberous Sclerosis Complex, run by University Hospital, Brest at 2 sites in France.
Trial summary
This study aims to investigate the factors (clinical, care-related and genetic) affecting renal outcome in patients with TSC (Tuberous sclerosis complex) Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Tuberous Sclerosis Complex
- How many people
- 150 participants
- Where
- 2 sitesFrance
- Study dates
- 13 Aug 2015to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with TSC and followed in one of the nephrology centers in the West of France
Who may be able to join
- Patient presenting with an isolated angiomyolipoma or
- Patient presenting with tuberous sclerosis complex combined with an angiomyolipoma or
- Patient presenting with tuberous sclerosis complex
- Patient not objecting to the study
Who cannot join
- ■Patient objecting to the study
Trial locations and contacts
2 sites in 1 country.
Yannick LE MEUR, MD PhD contact
France2 sites, 2 recruiting
- Recruiting
CHU Brest
Brest, 29200
Yannick LE MEUR, MD PhD, yannick.lemeur@chu-brest.fr
Yannick LE MEUR, MD PhD
- Recruiting
CHU Rennes
Rennes, 35033
Cecile VIGNEAU, MD PhD, cecile.vigneau@chu-rennes.fr
Cecile Vigneau, MD PhD
About this study
This study aims to investigate the factors (clinical, care-related and genetic) affecting renal outcome in patients with TSC (Tuberous sclerosis complex)
- Conditions
- Tuberous Sclerosis Complex
- Medical subject headings
- Tuberous Sclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of the renal function estimated by the MDRD GFR
Measured: 18 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2016 (estimated)
- Study start13 Aug 2015
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tuberous Sclerosis ComplexStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yannick LE MEUR, MD PhD, Study director, University Hospital, Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02887781
- Sponsor's protocol ID
- TSAR (RB 14.055)
- Acronym
- TSAR
- Status last verified
- Jan 2024
- First submitted
- 30 Aug 2016
- Last updated
- 5 Jan 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Presentation and Renal Outcome of Patients With Tuberous Sclerosis Complex and/or Renal Angiomyolipoma in the Great West Region of France
- ClinicalTrials.gov ID
- NCT02887781
- Acronym / sponsor ID
- TSAR / TSAR (RB 14.055)
- Conditions
- Tuberous Sclerosis Complex
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 13 Aug 2015 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 2 Sep 2016 (estimated)
- 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.
This study aims to investigate the factors (clinical, care-related and genetic) affecting renal outcome in patients with TSC (Tuberous sclerosis complex)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with TSC and followed in one of the nephrology centers in the West of France
Key inclusion criteria (4 listed)
- Patient presenting with an isolated angiomyolipoma or
- Patient presenting with tuberous sclerosis complex combined with an angiomyolipoma or
- Patient presenting with tuberous sclerosis complex
- Patient not objecting to the study
Key exclusion criteria (1 listed)
- ■Patient objecting to the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evolution of the renal function estimated by the MDRD GFR
Time frame: 18 months after inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
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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. This study is not recruiting at the moment.
Yannick LE MEUR, MD PhD contact
Yannick LE MEUR, MD PhD study director
University Hospital, Brest
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberous Sclerosis Complex, run by University Hospital, Brest at 2 sites 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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yannick LE MEUR, MD PhD (yannick.lemeur@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of the renal function estimated by the MDRD GFR (time frame: 18 months after inclusion). 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 5 Jan 2024.