Main
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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:
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ChiCTR |
Last refreshed on:
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1 February 2021 |
Main ID: |
ChiCTR2000039523 |
Date of registration:
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2020-10-30 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Safety and efficacy of everolimus in patients with renal angiomyolipoma associated with tuberous sclerosis: a case series study
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Scientific title:
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Safety and efficacy of Everolimus in patients with renal angiomyolipoma associated with tuberous sclerosis: a case series study |
Date of first enrolment:
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2020-12-01 |
Target sample size:
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case series:20; |
Recruitment status: |
Recruiting |
URL:
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http://www.chictr.org.cn/showproj.aspx?proj=63453 |
Study type:
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Observational study |
Study design:
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Sequential
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Phase:
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4
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Countries of recruitment
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China
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Contacts
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Name:
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Dong Xiu
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Address:
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6 Dahongluochang Street, Xicheng District, Beijing
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Telephone:
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+86 15850673072 |
Email:
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dongxiu315@163.com |
Affiliation:
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Peking University First Hospital |
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Name:
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Zhou Ying
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Address:
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6 Dahongluochang Street, Xicheng District, Beijing
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Telephone:
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+86 10-66110802 |
Email:
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zhouying0321@126.com |
Affiliation:
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Peking University First Hospital |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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LD2D.2
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tuberous sclerosis complex
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Intervention(s)
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case series:everolimus;
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Primary Outcome(s)
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Tumor size;
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Source(s) of Monetary Support
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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
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Ethics review
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Status: Not approved
Approval date: 26/08/2013
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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