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TSC1/2 gene detection and Everolimus treatment for renal angiomyolipoma associated with tuberous sclerosis complex

TSC1/2 gene detection and Everolimus treatment for renal angiomyolipoma associated with tuberous sclerosis complex

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OPN-16008236
Enrollment
Unknown
Registered
2016-04-07
Start date
2016-06-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

renal angiomyolipoma

Interventions

10mg Everolimus:Everolimus 10mg QD for three months
5mg Everolimus:Everolimus 5mg QD for six months

Sponsors

General Hospital of PLA
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosed of renal angiomyolipoma (more than two measurable lesions,the diameter more than 4cm in more than one lesion); 2. Male or female and 18 years of age or older; 3. Signed a informed consent; 4. Cooperate the follow-up; 5. No partial nephrectomy or renal surgery indications; 6. Good cardiopulmonary function.

Exclusion criteria

Exclusion criteria: 1. Serious illness (e.g., cardio-cerebrovascular disease, unable to cooperate to complete related inspection); 2. Mental disorder or not cooperation; 3. Malignant lesions cannot be excluded by imaging examination; 4. Can't cooperate with the visitor; 5. Tumor rupture hemorrhage appeared in the past six months. 6. Moderately severe anemia, or lung infection.

Design outcomes

Primary

MeasureTime frame
the rate of best ratio relieve patients;

Secondary

MeasureTime frame
Objective response rate;Disease control rates;Disease progression-free time;

Countries

China

Contacts

Public ContactGuo Gang

v

greenguo@sina.com+86 10-66875509

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026