NCT05745142

A Study to go Back Into Records and Observe How People With Metastatic Renal Cell Carcinoma (mRCC) Who Received a Medicine Called Sunitinib Responded to This Medicine.

A Retrospective Registry Based Study for Evaluating Treatment Response in Patients Targeted Treated With Metastatic Renal Cell Carcinoma (mRCC) With Sunitinib in First-line Therapy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 376 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to understand how patients with mRCC respond to the study medicine (called sunitinib) when they receive it as the first line of treatment after finding out the cause for the disease. This study will look into how different and how well groups of people with high chances of developing the disease respond to the study medicine. All data for this study will be anonymously extracted from data already entered in RCC Registry which is owned by Turkish Oncology Group Association (TOGD). This study will pull out records from the Registry between 01-Mar-2019 and 30-Oct-2022 that belongs to people: * who are Turkish citizens * who are older than 18 years * who were found out to have mRCC * who received sunitinib as the first line treatment after finding out the cause for the disease This study will look at the responses, experiences and how long the patients use the study medicine sunitinib.

Detailed description

This study is designed as a local, non-interventional, retrospective, registry-based study to observe treatment response in patients with metastatic Renal Cell Carcinoma with Sunitinib First-Line Therapy based on data extracted and analyzed from the RCC Registry. The annual disease burden in contributing centers to RCC Registry is approximately 100 patient/center, the treatment of an average of 250 patients per year is continued in the centers. Therefore, it is estimated that information of approximately 400 eligible patients who were registered in RCC Registry from 2019 to 2022 will be included in the analysis. RCC Registry will be used as the sole data source for this study. For this purpose, no Case Report Forms (CRFs) or Data Collection Tools (DCTs) will be utilized, but the RCC Registry database will be used directly. Eligible patients' data will be anonymized and extracted for analysis by the registry owner, for this study.

Conditions

• Carcinoma, Renal Cell
• Clear-cell Metastatic Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Sunitinib	as provided in real world practice

Timeline

• Start date: 2023-02-23
• Primary completion: 2023-02-23
• Completion: 2023-02-23
• First posted: 2023-02-27
• Last updated: 2024-08-05
• Results posted: 2024-08-05

Locations

1 site across 1 country: Turkey (Türkiye)