NCT02887781

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2015

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 13, 2015

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

August 30, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 2, 2016

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

January 5, 2024

Status Verified

January 1, 2024

Enrollment Period

9.4 years

First QC Date

August 30, 2016

Last Update Submit

January 3, 2024

Conditions

Tuberous Sclerosis Complex

Outcome Measures

Primary Outcomes (1)

  • Evolution of the renal function estimated by the MDRD GFR

    18 months after inclusion

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with TSC and followed in one of the nephrology centers in the West of France

You may qualify if:

  • 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

You may not qualify if:

  • ■Patient objecting to the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU Brest

Brest, 29200, France

RECRUITING

CHU Rennes

Rennes, 35033, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole Blood

MeSH Terms

Conditions

Tuberous Sclerosis

Condition Hierarchy (Ancestors)

HamartomaNeoplasmsNeoplasms, Multiple PrimaryNeoplastic Syndromes, HereditaryMalformations of Cortical Development, Group IMalformations of Cortical DevelopmentNervous System MalformationsNervous System DiseasesNeurocutaneous SyndromesHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, Inborn

Study Officials

  • Yannick LE MEUR, MD PhD

    University Hospital, Brest

    STUDY DIRECTOR

Central Study Contacts

Yannick LE MEUR, MD PhD

CONTACT

yannick.lemeur@chu-brest.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2016

First Posted

September 2, 2016

Study Start

August 13, 2015

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

January 5, 2024

Record last verified: 2024-01

Locations

FR(2)