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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.

Pfizer logo

Pfizer

Status

Completed

Conditions

Clear-cell Metastatic Renal Cell Carcinoma
Carcinoma, Renal Cell

Treatments

Drug: Sunitinib

Study type

Observational

Funder types

Industry

Identifiers

NCT05745142
A6181235

Details and patient eligibility

About

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.

Full 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.

Enrollment

376 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Being a Turkish citizen.
  • Being older than 18 years-old.
  • Being clinically diagnosed with mRCC and treated.
  • Being treated with Sunitinib in first line

Exclusion criteria

  • Patients whose treatment was initiated but excluded from follow-up for any reason.

Trial design

376 participants in 1 patient group

metastatic Renal Cell Carcinoma patients
Description:
metastatic Renal Cell Carcinoma patients with clear cell histology.
Treatment:
Drug: Sunitinib

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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