Clinical trial NCT02776644: Clinical Outcome Of Advanced Renal Cell Carcinoma In Taiwan
Official title: CLINICAL OUTCOME OF ADVANCED RENAL CELL CARCINOMA IN TAIWAN, A RETROSPECTIVE NHIA DATABASE ANALYSIS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Cell Carcinoma
Keywords: renal cell carcinoma
sunitinib, pazopanib
temsirolimus
sorafenib
everolimus
interferon alpha
interleukin 2
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2016-05-18
Enrollment: 1349
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: advanced/metastatic renal cell carcnioma

Brief summary: The clinical outcome of advanced / metastatic renal cell carcinoma has been changed since targeted therapy being widely applied. This study will retrospectively analyse the clinical outcome of advanced renal cell carcinoma captured in Taiwan National Health Insurance Research Database.

Detailed description: Targeted therapy agents have significantly changed the clinical outcome of advanced / metastatic renal cell carcinoma. However, the dosing pattern varied and might result in impact to duration of treatment. In Taiwan, National Health Insurance system has a coverage more than 90% of population and thus can serve as an appropriate database for further analysis on Taiwanese advanced renal cell carcinoma. This study will retrospectively analyse the clinical outcome of advanced renal cell carcinoma captured in Taiwan National Health Insurance Research Database.

Eligibility criteria: Inclusion Criteria:

* advanced/metastatic renal cell carcinoma

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Duration of Sunitinib and Pazopanib Treatment in Participants
timeFrame: during the observation period of 11 years
measure: Cumulative Number of Capsules of Sunitinib and Pazopanib Administered From the Time of Start of Treatment Up to Month 3
timeFrame: from the time of start of treatment up to Month 3
measure: Cumulative Number of Capsules of Sunitinib and Pazopanib Administered From Month 3 to Month 6
timeFrame: Month 3 up to Month 6
measure: Cumulative Number of Capsules of Sunitinib and Pazopanib Administered From Month 6 to Month 9
timeFrame: Month 6 up to Month 9
measure: Cumulative Number of Capsules of Sunitinib and Pazopanib Administered From Month 9 to Month 12
timeFrame: Month 9 up to Month 12
measure: Cumulative Number of Capsules of Sunitinib and Pazopanib Administered From the Time of Start of Treatment Up to Month 12
timeFrame: from the time of start of treatment up to Month 12
measure: Overall Renal Cell Carcinoma (RCC) Related Direct Medical Cost From the Diagnosis Date to the First Dose of Sunitinib and Pazopanib
timeFrame: from the time of disease diagnosis till the first dose of Sunitinib and Pazopanib
measure: Overall Renal Cell Carcinoma (RCC) Related Direct Medical Cost From the First Dose of the Sunitinib and Pazopanib to the End of Observation Period
timeFrame: From first dose of drug to the end of observation period (up to 11 years)
measure: Overall Survival
timeFrame: from the time of first prescription of Sunitinib or Pazopanib till date of death (during the observation period of 11 years)
measure: Number of Participants With Changes in Prescription Patterns of Antihypertensive Medication From the Time of First Dose of Drug at Month 1
timeFrame: time of first dose of the drug, Month 1
measure: Number of Participants With Changes in Prescription Patterns of Antihypertensive Medication From the Time of First Dose of Drug at Month 3
timeFrame: time of first dose of the drug, Month 3
measure: Number of Participants With Changes in Prescription Patterns of Antihypertensive Medication From the Time of First Dose of Drug at Month 6
timeFrame: the first dose of the drug, Month 6
measure: Number of Participants With Changes in Prescription Patterns of Antihypertensive Medication From the Time of First Dose of Drug at Month 12
timeFrame: the first dose of the medication, Month 12
measure: Number of Participants Who Received Antihypertensive Medication at Baseline
timeFrame: Baseline (at the beginning of 11 year observation period)
measure: Number of Participants Who Received Antihypertensive Medication From Baseline to Month 1
timeFrame: Baseline (at the beginning of 11 year observation period) up to Month 1
measure: Number of Participants Who Received Antihypertensive Medication From Month 1 to Month 3
timeFrame: Month 1 up to Month 3 since Sunitinib or Pazopanib initiation (during the observation period of 11 years)
measure: Number of Participants Who Received Antihypertensive Medication From Month 3 to Month 6
timeFrame: Month 3 up to Month 6 since Sunitinib or Pazopanib initiation (during the observation period of 11 years)
measure: Number of Participants Who Received Antihypertensive Medication From Month 6 to Month 12
timeFrame: Month 6 up to Month 12 since Sunitinib or Pazopanib initiation (during the observation period of 11 years)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: