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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05363072
Recruitment Status : Completed
First Posted : May 5, 2022
Last Update Posted : April 10, 2023
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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Brief Summary:
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.

Condition or disease
Renal Cell Cancer Renal Cell Carcinoma Cancer of Kidney Cancer of the Kidney Kidney Cancer Kidney Neoplasms Renal Cancer

Study Design
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Study Type : Observational
Actual Enrollment : 191 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Registry-based Non-interventional Analysis of Advanced/Metastatic Renal Carcinoma Treatment Patterns and Outcomes in the Hospital District of Southwest Finland.
Actual Study Start Date : June 1, 2022
Actual Primary Completion Date : September 30, 2022
Actual Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Cancer

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Demographical Characteristics of Participants (treated) [ Time Frame: During post-index period (January 2010 - December 2021) ]
  2. Demographical Characteristics of Participants (non-treated) [ Time Frame: During post-index period (January 2010 - December 2021) ]
  3. International Metastatic Database Consortium (IMDC) Risk Group Status at Initiation of Treatment (treated) [ Time Frame: During post-index period (January 2010 - December 2021) ]
  4. IMDC Risk Group Status at Initiation of Treatment (non-treated) [ Time Frame: During post-index period (January 2010 - December 2021) ]
  5. Number of Treatments Received in the Advanced/Metastatic Renal Cell Carcinoma (mRCC) Setting [ Time Frame: During post-index period (January 2010 - December 2021) ]
  6. Number of Treatment Sequences Received in the mRCC Setting [ Time Frame: During post-index period (January 2010 - December 2021) ]
  7. Time to next treatment (TTNT) [ Time Frame: During post-index period (January 2010 - December 2021) ]
  8. Overall Survival (OS) [ Time Frame: During post-index period (January 2010 - December 2021) ]

Secondary Outcome Measures :
  1. Number of Participants With Morbidities with Metastatic RCC [ Time Frame: During post-index period (January 2010 - December 2021) ]
  2. Healthcare Resource Utilization [ Time Frame: During post-index period (January 2010 - December 2021) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05363072


Locations
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Finland
Pfizer Finland
Helsinki, Finland, 00330
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT05363072    
Other Study ID Numbers: A4061098
FIN-RCC-RWD ( Other Identifier: Alias Study Number )
First Posted: May 5, 2022    Key Record Dates
Last Update Posted: April 10, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.
Keywords provided by Pfizer:
Advanced/ metastatic RCC (mRCC)
Real World Evidence
Registry based study
Non-interventional study
Axitinib
Sunitinib
 Pazopanib
Cabozantinib
Nivolumab
Sorafenib
Everolimus
Ipilimumab
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Kidney Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Urologic Neoplasms
 Urogenital Neoplasms
Neoplasms by Site
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Kidney Diseases
Urologic Diseases
Male Urogenital Diseases