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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05363072
Other study ID # A4061098
Secondary ID FIN-RCC-RWD
Status Completed
Phase
First received
Last updated
Start date June 1, 2022
Est. completion date September 30, 2022

Study information

Verified date April 2023
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 191
Est. completion date September 30, 2022
Est. primary completion date September 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Locations

Country Name City State
Finland Pfizer Finland Helsinki

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Demographical Characteristics of Participants (treated) During post-index period (January 2010 - December 2021)
Primary Demographical Characteristics of Participants (non-treated) During post-index period (January 2010 - December 2021)
Primary International Metastatic Database Consortium (IMDC) Risk Group Status at Initiation of Treatment (treated) During post-index period (January 2010 - December 2021)
Primary IMDC Risk Group Status at Initiation of Treatment (non-treated) During post-index period (January 2010 - December 2021)
Primary Number of Treatments Received in the Advanced/Metastatic Renal Cell Carcinoma (mRCC) Setting During post-index period (January 2010 - December 2021)
Primary Number of Treatment Sequences Received in the mRCC Setting During post-index period (January 2010 - December 2021)
Primary Time to next treatment (TTNT) During post-index period (January 2010 - December 2021)
Primary Overall Survival (OS) During post-index period (January 2010 - December 2021)
Secondary Number of Participants With Morbidities with Metastatic RCC During post-index period (January 2010 - December 2021)
Secondary Healthcare Resource Utilization During post-index period (January 2010 - December 2021)
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