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

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: Kidney Cancer; Kidney Neoplasms; Renal Cell Carcinoma; Renal Cancer; Renal Cell Cancer; Cancer of the Kidney; Cancer of Kidney

• Study Type: Observational
• Enrollment (Actual): 1112

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland, 00330
    • Pfizer Finland

Participation Criteria

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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants According to Co-Diagnoses Before Index	Number of participants according to co-diagnoses 3 years before participant's index were reported in this outcome measure. Index date was defined as the date of treatment initiation for mRCC. Co-diagnoses were based on International Classification of Diseases 10th revision (ICD-10) codes. One participant may have more than one co-diagnoses.	3 years prior to index date
Number of Participants According to Co-Diagnoses After Index	Number of participants according to co-diagnoses up to 3 years after participant's index were reported in this outcome measure. Index date was defined as the date of treatment initiation for mRCC. Co-diagnoses were based on ICD-10 codes. One participant may have more than one co-diagnoses.	Up to 3 years after index date
Body Mass Index (BMI)	BMI of participants at index was reported in this outcome measure. Index date was defined as the date of treatment initiation for mRCC.	At index
Mean Outpatient Visits and Emergent Room Visits Per Patient Year	The number of outpatient visits and emergency room (ER) visits per patient year for all contacts, disease-specific contacts and other contacts were reported in this outcome measure. All contacts included disease specific contacts and other contacts. Per patient year was defined as total sum of events divided by the total sum of follow-up length of the participants.	Up to maximum of 12 years (retrospective data collection of 1 month)
Mean Number of Hospitalizations Per Patient Year	The number of hospitalization visits per patient year for all contacts, disease-specific contacts and other contacts were reported in this outcome measure. All contacts included disease specific contacts and other contacts. Per patient year was defined as total sum of events divided by the total sum of follow-up length of the participants.	Up to maximum of 12 years (retrospective data collection of 1 month)
Mean Number of Procedures and Surgeries Per Patient Year	Number of procedures and surgeries per patient year were reported in this outcome measure. Per patient year was defined as total sum of events divided by the total sum of follow-up length of the participants.	Up to maximum of 12 years (retrospective data collection of 1 month)
Number of Participants According to Treatment	Number of participants receiving each treatment per treatment line were reported in this outcome measure.	From initiation of treatment until death, moved outside of HDSF or end of study (maximum up to 12 years)
Number of Participants According to Treatment Per Treatment Line Between 2010 to 2017	Number of participants according to treatment per treatment line between 2010 to 2017 were reported in this outcome measure.	Anytime between January 2010 to December 2017 (maximum up to 8 years)
Number of Participants According to Treatment Per Treatment Line Between 2018 to 2021	Number of participants according to treatment per treatment line between 2018 to 2021 were reported in this outcome measure.	Anytime between January 2018 to December 2021 (maximum up to 4 years)
Mean Number of Laboratory Days Per Patient Year	Number of laboratory days per patient year were reported in this outcome measure. Per patient year was defined as total sum of events divided by the total sum of follow-up length of the participants.	Up to maximum of 12 years (retrospective data collection of 1 month)
Mean Number of Laboratory Days Per Patient Year Stratified by International Metastatic Database Consortium (IMDC) Risk Category	Number of laboratory days per patient year stratified by IMDC risk category were reported in this outcome measure. IMDC risk category included Score 0= favorable risk, no missing values allowed; Score 1-2= intermediate risk, total score=1: maximum 1 risk factor can have missing value, total score=2: no missing values allowed; Score 3-6= poor risk, maximum 3 risk factors allowed to have missing values; Unknown risk= when none of the above risk categories could be assigned. Per patient year was defined as total sum of events divided by the total sum of follow-up length of the participants.	Up to maximum of 12 years (retrospective data collection of 1 month)
Number of Participants Classified According to Karnofsky Performance Status (KPS) Stratified by IMDC Risk Category	KPS:used for rating activities of daily living on 11-step scale from 0-100,higher score=participant better able to carry daily activities.Score:100=normal no complaints;no disease evidence,90=able to carry normal activity;minor signs/symptoms of disease,80=normal activity with effort;some signs/symptoms, 70=cares for self;unable to carry normal activity,60=required occasional assistance,able to care for personal needs,50=required considerable assistance & frequent medical care,40=disabled;required special care/assistance,30=severely disabled;hospital admission indicated;20=very sick;hospital admission necessary,10=moribund & 0=dead.IMDC risk category:0=favorable risk,no missing values allowed;1-2=intermediate risk,total score=1:max 1 risk factor could have missing value,total score=2:no missing values allowed;3-6=poor risk,max 3 risk factors allowed to have missing values; Unknown=none of the above risk categories could be assigned.Index date=date of treatment initiation for mRCC.	At index
Number of Participants Classified According to Pathological Diagnosis (PAD) Histology	Number of participants classified according to PAD were reported in this outcome measure. Histology included chromophobe renal cell carcinoma, clear cell renal cell carcinoma, oncocytoma renal cell carcinoma, papillary renal cell carcinoma, other (chromophobe, oncocytoma, and papillary renal cell carcinoma included if not reported separately) and missing. Index date was defined as the date of treatment initiation for mRCC.	At index

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival	Overall Survival was defined as the time from index (start of each treatment line) until death due to any cause or end of study. Overall survival according to treatment lines (1, 2 or 3) was presented in this outcome measure.	From index until death due to any cause or end of study (maximum up to 12 years)
Time to Next Treatment (TTNT)	Time to next treatment (TTNT) was defined as the interval between the start of current treatment and the start of the next-line treatment or death or end of study. Kaplan-Meier method was used for analysis. TTNT according to treatment lines were presented in this outcome measure.	From start of current treatment to date of next line treatment or death or end of study (maximum up to 12 years)
Number of Participants Classified According to IMDC Risk Group Status at Initiation of Treatment	Number of participants classified according to IMDC risk group status at initiation of treatment were reported in this outcome measure. IMDC risk category included score 0= favorable risk, no missing values allowed; score 1-2= Intermediate risk, total score=1: maximum 1 risk factor can have missing value, total score=2: no missing values allowed; Score 3-6= Poor risk, maximum 3 risk factors allowed to have missing values; Unknown risk= when none of the above risk categories could be assigned. Index date was defined as the date of treatment initiation for mRCC.	At index
Mean Absolute Costs Associated With Healthcare Resource Utilization	Absolute costs associated with healthcare resource utilization for all contacts, disease-specific contacts and other contacts was reported in this outcome measure. All contacts included ER visits, hospitalizations, and outpatient contacts.	Up to maximum of 12 years (retrospective data collection of 1 month)

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2022
• Primary Completion (Actual): June 8, 2022
• Study Completion (Actual): June 8, 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): October 1, 2024
• Last Update Submitted That Met QC Criteria: June 12, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Sorafenib; Nivolumab; Everolimus; Ipilimumab; Pazopanib; Non-interventional study; Real World Evidence; Cabozantinib; Axitinib; Sunitinib; Advanced/ metastatic RCC (mRCC); Registry based study
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Neoplasms; Carcinoma, Renal Cell; Carcinoma
• 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.