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Clinical Presentation and Renal Outcome of Patients With Tuberous Sclerosis Complex and/or Renal Angiomyolipoma in the Great West Region of France

Study Purpose

This study aims to investigate the factors (clinical, care-related and genetic) affecting renal outcome in patients with TSC (Tuberous sclerosis complex)

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 8 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion criteria of study participants.

  • - 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.
Exclusion criteria of study participants. ■Patient objecting to the study

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02887781
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University Hospital, Brest
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Yannick LE MEUR, MD PhD
Principal Investigator Affiliation University Hospital, Brest
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Tuberous Sclerosis Complex

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

CHU Brest, Brest, France

Status

Recruiting

Address

CHU Brest

Brest, , 29200

Site Contact

Yannick LE MEUR, MD PhD

[email protected]

CHU Rennes, Rennes, France

Status

Recruiting

Address

CHU Rennes

Rennes, , 35033

Site Contact

Cecile VIGNEAU, MD PhD

[email protected]

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