A Study to Describe the Kidney Cancer Patient Population Treatment, and Results in the Hospital District of Southwest Finland.

April 4, 2023 updated by: Pfizer

Registry-based Non-interventional Analysis of Advanced/Metastatic Renal Carcinoma Treatment Patterns and Outcomes in the Hospital District of Southwest Finland.

The purpose of the study is to find out how patients with advanced kidney cancer have been treated in the hospital district of Southwest Finland over time.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

191

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland, 00330
        • Pfizer Finland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients with advanced/metastatic RCC and medical records available at the in the Hospital District of Southwest Finland (HDSF) HDSF registry

Description

Inclusion Criteria:

For the characteristic group:

  • Diagnosis of renal cell carcinoma (International Classification of Diseases 10th revision [ICD]-10:64) during 01 January 2010 and 31 December 2021

For the mRCC group:

  • ICD-10 diagnosis code for metastasis (C77*-C79*), or
  • American Joint Committee on Cancer (AJCC) stage 4, or AJCC stage data potentially not available for all patients
  • Visit to oncologist (specialty code 65) with RCC as main diagnosis, or In Finland, the ICD-10 codes for metastatic disease are rarely used. In contrast, RCC patients visit oncologist, when and only when disease metastasises and therefore, the visit can be used as a proxy to a metastatic disease
  • Initiation of treatment for mRCC

Exclusion Criteria:

For the characteristic group:

  • Prevalent mRCC patients (i.e. diagnosis of metastatic RCC before 01 January 2010)
  • Prevalent mRCC patients (i.e. diagnosis of RCC before 01 January 2010) if there is no records of metastatic disease during 2010-2021

For the mRCC group:

  • Prevalent patients with mRCC (i.e. diagnosis of metastatic RCC before 01 January 2010)
  • Patients without treatment for mRCC

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Demographical Characteristics of Participants (treated)
Time Frame: During post-index period (January 2010 - December 2021)
During post-index period (January 2010 - December 2021)
Demographical Characteristics of Participants (non-treated)
Time Frame: During post-index period (January 2010 - December 2021)
During post-index period (January 2010 - December 2021)
International Metastatic Database Consortium (IMDC) Risk Group Status at Initiation of Treatment (treated)
Time Frame: During post-index period (January 2010 - December 2021)
During post-index period (January 2010 - December 2021)
IMDC Risk Group Status at Initiation of Treatment (non-treated)
Time Frame: During post-index period (January 2010 - December 2021)
During post-index period (January 2010 - December 2021)
Number of Treatments Received in the Advanced/Metastatic Renal Cell Carcinoma (mRCC) Setting
Time Frame: During post-index period (January 2010 - December 2021)
During post-index period (January 2010 - December 2021)
Number of Treatment Sequences Received in the mRCC Setting
Time Frame: During post-index period (January 2010 - December 2021)
During post-index period (January 2010 - December 2021)
Time to next treatment (TTNT)
Time Frame: During post-index period (January 2010 - December 2021)
During post-index period (January 2010 - December 2021)
Overall Survival (OS)
Time Frame: During post-index period (January 2010 - December 2021)
During post-index period (January 2010 - December 2021)

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With Morbidities with Metastatic RCC
Time Frame: During post-index period (January 2010 - December 2021)
During post-index period (January 2010 - December 2021)
Healthcare Resource Utilization
Time Frame: During post-index period (January 2010 - December 2021)
During post-index period (January 2010 - December 2021)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Actual)

September 30, 2022

Study Completion (Actual)

September 30, 2022

Study Registration Dates

First Submitted

May 2, 2022

First Submitted That Met QC Criteria

May 2, 2022

First Posted (Actual)

May 5, 2022

Study Record Updates

Last Update Posted (Actual)

April 10, 2023

Last Update Submitted That Met QC Criteria

April 4, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A4061098
  • FIN-RCC-RWD (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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