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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ChiCTR
Last refreshed on: 1 February 2021
Main ID:  ChiCTR2000039523
Date of registration: 2020-10-30
Prospective Registration: Yes
Primary sponsor: Department of Pharmacy, Peking University First Hospita
Public title: Safety and efficacy of everolimus in patients with renal angiomyolipoma associated with tuberous sclerosis: a case series study
Scientific title: Safety and efficacy of Everolimus in patients with renal angiomyolipoma associated with tuberous sclerosis: a case series study
Date of first enrolment: 2020-12-01
Target sample size: case series:20;
Recruitment status: Recruiting
URL:  http://www.chictr.org.cn/showproj.aspx?proj=63453
Study type:  Observational study
Study design:  Sequential  
Phase:  4
Countries of recruitment
China
Contacts
Name: Dong Xiu   
Address:  6 Dahongluochang Street, Xicheng District, Beijing
Telephone: +86 15850673072
Email: dongxiu315@163.com
Affiliation:  Peking University First Hospital
Name: Zhou Ying   
Address:  6 Dahongluochang Street, Xicheng District, Beijing
Telephone: +86 10-66110802
Email: zhouying0321@126.com
Affiliation:  Peking University First Hospital
Key inclusion & exclusion criteria
Inclusion criteria: Patients must meet all of the following criteria to be included:
(1) TsC-RAML was diagnosed;
(2) CT or MRI showed that the longest diameter of TSC-RAML was >= 3 cm;
(3) Take everolimus (brand name: AFINITOR);
(4) With good compliance, complete follow-up information can be obtained.

Exclusion criteria: Patients who meet one of the following criteria will be excluded:
(1) The dosage of everolimus cannot be obtained;
(2) The primary indicator cannot be obtained;
(3) The demographic information cannot be obtained.


Age minimum: 0
Age maximum: 100
Gender: Both
Health Condition(s) or Problem(s) studied
LD2D.2
tuberous sclerosis complex
Intervention(s)
case series:everolimus;
Primary Outcome(s)
Tumor size;
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
The Development Center for Medical Science & Technology, National Health Commission of the People's Republic of China supported the National Scientific and Technological Major Project
Secondary Sponsor(s)
Ethics review
Status: Not approved
Approval date: 26/08/2013
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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