Clinical Presentation and Renal Outcome of Patients With... | NCT02887781

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

NCT02887781

Sponsor

University Hospital, Brest

Status

Unknown status

Last Update Posted

Jan 5, 2024Actual

Enrollment

150Estimated

Phase

Not provided

Conditions

Tuberous Sclerosis Complex

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 13, 2015Actual

Primary Completion Date

Dec 31, 2024Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Aug 30, 2016

First Submission Date that Met QC Criteria

Aug 30, 2016

First Posted Date

Sep 2, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 3, 2024

Last Update Posted Date

Jan 5, 2024Actual

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

150Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evolution of the renal function estimated by the MDRD GFR		18 months after inclusion

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yannick LE MEUR, MD PhD	Contact			yannick.lemeur@chu-brest.fr

Overall Officials

Name	Affiliation	Role
Yannick LE MEUR, MD PhD	University Hospital, Brest	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Brest	Recruiting	Brest		29200	France

Condition Browse Module

MeSH Terms

ID	Term
D014402	Tuberous Sclerosis

Ancestor Terms

ID	Term
D006222	Hamartoma
D009369	Neoplasms
D009378	Neoplasms, Multiple Primary
D009386	Neoplastic Syndromes, Hereditary

Browse Leaves

Not provided

Browse Branches

Not provided