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.

NCT ID: NCT05745142

Last Updated: 2024-08-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

376 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-23

Study Completion Date

2023-02-23

Brief Summary

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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

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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

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Carcinoma, Renal Cell Clear-cell Metastatic Renal Cell Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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metastatic Renal Cell Carcinoma patients

metastatic Renal Cell Carcinoma patients with clear cell histology.

Sunitinib

Intervention Type DRUG

as provided in real world practice

Interventions

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Sunitinib

as provided in real world practice

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=A6181235

To obtain contact information for a study center near you, click here.

Other Identifiers

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A6181235

Identifier Type: -

Identifier Source: org_study_id

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