Clinical trial NCT05363072: A Study to Describe the Kidney Cancer Patient Population Treatment, and Results in the Hospital District of Southwest Finland.
Official title: Registry-based Non-interventional Analysis of Advanced/Metastatic Renal Carcinoma Treatment Patterns and Outcomes in the Hospital District of Southwest Finland.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Cell Cancer
Renal Cell Carcinoma
Cancer of Kidney
Cancer of the Kidney
Kidney Cancer
Kidney Neoplasms
Renal Cancer
Keywords: Advanced/ metastatic RCC (mRCC)
Real World Evidence
Registry based study
Non-interventional study
Axitinib
Sunitinib
Pazopanib
Cabozantinib
Nivolumab
Sorafenib
Everolimus
Ipilimumab
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2022-05-05
Enrollment: 1112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
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

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.


Eligibility 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

Primary outcomes:
measure: Number of Participants According to Co-Diagnoses Before Index
timeFrame: 3 years prior to index date
measure: Number of Participants According to Co-Diagnoses After Index
timeFrame: Up to 3 years after index date
measure: Body Mass Index (BMI)
timeFrame: At index
measure: Mean Outpatient Visits and Emergent Room Visits Per Patient Year
timeFrame: Up to maximum of 12 years (retrospective data collection of 1 month)
measure: Mean Number of Hospitalizations Per Patient Year
timeFrame: Up to maximum of 12 years (retrospective data collection of 1 month)
measure: Mean Number of Procedures and Surgeries Per Patient Year
timeFrame: Up to maximum of 12 years (retrospective data collection of 1 month)
measure: Number of Participants According to Treatment
timeFrame: From initiation of treatment until death, moved outside of HDSF or end of study (maximum up to 12 years)
measure: Number of Participants According to Treatment Per Treatment Line Between 2010 to 2017
timeFrame: Anytime between January 2010 to December 2017 (maximum up to 8 years)
measure: Number of Participants According to Treatment Per Treatment Line Between 2018 to 2021
timeFrame: Anytime between January 2018 to December 2021 (maximum up to 4 years)
measure: Mean Number of Laboratory Days Per Patient Year
timeFrame: Up to maximum of 12 years (retrospective data collection of 1 month)
measure: Mean Number of Laboratory Days Per Patient Year Stratified by International Metastatic Database Consortium (IMDC) Risk Category
timeFrame: Up to maximum of 12 years (retrospective data collection of 1 month)
measure: Number of Participants Classified According to Karnofsky Performance Status (KPS) Stratified by IMDC Risk Category
timeFrame: At index
measure: Number of Participants Classified According to Pathological Diagnosis (PAD) Histology
timeFrame: At index
Secondary outcomes:
Other outcomes:
measure: Overall Survival
timeFrame: From index until death due to any cause or end of study (maximum up to 12 years)
measure: Time to Next Treatment (TTNT)
timeFrame: From start of current treatment to date of next line treatment or death or end of study (maximum up to 12 years)
measure: Number of Participants Classified According to IMDC Risk Group Status at Initiation of Treatment
timeFrame: At index
measure: Mean Absolute Costs Associated With Healthcare Resource Utilization
timeFrame: Up to maximum of 12 years (retrospective data collection of 1 month)
Locations:
city: Helsinki
country: Finland
facility: Pfizer Finland
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: