Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02887781
Recruitment Status : Recruiting
First Posted : September 2, 2016
Last Update Posted : November 29, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

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

Condition or disease
Tuberous Sclerosis Complex

Layout table for study information
Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Presentation and Renal Outcome of Patients With Tuberous Sclerosis Complex and/or Renal Angiomyolipoma in the Great West Region of France
Actual Study Start Date : August 13, 2015
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020





Primary Outcome Measures :
  1. Evolution of the renal function estimated by the MDRD GFR [ Time Frame: 18 months after inclusion ]

Biospecimen Retention:   Samples With DNA
Whole Blood


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   8 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with TSC and followed in one of the nephrology centers in the West of France
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02887781


Contacts
Layout table for location contacts
Contact: Yannick LE MEUR, MD PhD yannick.lemeur@chu-brest.fr

Locations
Layout table for location information
France
CHU Brest Recruiting
Brest, France, 29200
Contact: Yannick LE MEUR, MD PhD       yannick.lemeur@chu-brest.fr   
Principal Investigator: Yannick LE MEUR, MD PhD         
CHU Rennes Recruiting
Rennes, France, 35033
Contact: Cecile VIGNEAU, MD PhD       cecile.vigneau@chu-rennes.fr   
Principal Investigator: Cecile Vigneau, MD PhD         
Sponsors and Collaborators
University Hospital, Brest
Investigators
Layout table for investigator information
Study Director: Yannick LE MEUR, MD PhD University Hospital, Brest

Layout table for additonal information
Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT02887781     History of Changes
Other Study ID Numbers: TSAR (RB 14.055)
First Posted: September 2, 2016    Key Record Dates
Last Update Posted: November 29, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Layout table for MeSH terms
Tuberous Sclerosis
Angiomyolipoma
Sclerosis
Pathologic Processes
Hamartoma
Neoplasms
Neoplasms, Multiple Primary
Neoplastic Syndromes, Hereditary
Malformations of Cortical Development, Group I
Malformations of Cortical Development
Nervous System Malformations
Nervous System Diseases
Neurocutaneous Syndromes
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Congenital Abnormalities
Genetic Diseases, Inborn
Neoplasms, Adipose Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Perivascular Epithelioid Cell Neoplasms