Pharmaco-Economic Study of Treatment Options in Patients With Advanced RCC

Renal Cell Carcinoma Clinical Trial

Official title:

Patients Characteristics, Treatment Utilization, Costs and Outcomes in Patients With Advanced or Metastatic Renal Cell Carcinoma (RCC) Who Received at Least One Prior Vascular Endothelial Growth Factor (VEGF)-Targeted Therapy in Taiwan

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03699579
• Other study ID #: A-TW-60000-022
• Status: Completed
• Start date: February 22, 2019
• Est. completion date: June 23, 2019

Study information

• Verified date: August 2019
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a retrospective cohort study aiming to collect data on patients' characteristics, resource utilization, adverse events management and calculate costs attributed to current treatments of advance RCC patients who have received at least one prior VEGF-targeted therapy in Taiwan from National Health Insurance (NHI) perspective.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 23, 2019
• Est. primary completion date: June 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with confirmed diagnosis of clear-cell renal cell carcinoma

• Patients with evidence of metastatic disease

• Patients who have received at least one previous VEGFR-targeted therapy, i.e sunitinib, pazopanib or sorafenib

• Patients who received care at the selected medical centers, utilizing the National Health Insurance (NHI) reimbursed system at the time of the disease

Exclusion Criteria:

• Patients enrolled in any clinical trial involving anti-cancer therapy

• Pregnant woman

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma
• Renal Cell Carcinoma Metastatic

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication usage		From start point for 2.5 months
Primary	Treatment's duration		From start point for 2.5 months
Secondary	Cost of medication used		From start point for 2.5 months
Secondary	Costs of adverse event management	(total calculated costs attributed to Adverse Effects (AEs) management according to the attached list of adverse events	From start point for 2.5 months
Secondary	Frequency of health resource usage	Outpatient department visits, CT scan, blood test number and types	From start point for 2.5 months
Secondary	Cost of health resource usage	Outpatient department visits, CT scan, blood test number and types	From start point for 2.5 months