A Study to Describe the Kidney Cancer Patient Population Treatment, and Results in the Hospital District of Southwest Finland.
- Conditions
- Renal Cell CancerRenal Cell CarcinomaKidney CancerKidney NeoplasmsRenal CancerCancer of KidneyCancer of the Kidney
- Registration Number
- NCT05363072
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1112
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
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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Participants According to Co-Diagnoses After Index Up to 3 years after index date 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.
Body Mass Index (BMI) At index BMI of participants at index was reported in this outcome measure. Index date was defined as the date of treatment initiation for mRCC.
Mean Outpatient Visits and Emergent Room Visits Per Patient Year Up to maximum of 12 years (retrospective data collection of 1 month) 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.
Number of Participants According to Co-Diagnoses Before Index 3 years prior to index date 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.
Mean Number of Hospitalizations Per Patient Year Up to maximum of 12 years (retrospective data collection of 1 month) 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.
Mean Number of Procedures and Surgeries Per Patient Year Up to maximum of 12 years (retrospective data collection of 1 month) 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.
Number of Participants According to Treatment From initiation of treatment until death, moved outside of HDSF or end of study (maximum up to 12 years) Number of participants receiving each treatment per treatment line were reported in this outcome measure.
Number of Participants According to Treatment Per Treatment Line Between 2010 to 2017 Anytime between January 2010 to December 2017 (maximum up to 8 years) Number of participants according to treatment per treatment line between 2010 to 2017 were reported in this outcome measure.
Number of Participants According to Treatment Per Treatment Line Between 2018 to 2021 Anytime between January 2018 to December 2021 (maximum up to 4 years) Number of participants according to treatment per treatment line between 2018 to 2021 were reported in this outcome measure.
Mean Number of Laboratory Days Per Patient Year Up to maximum of 12 years (retrospective data collection of 1 month) 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.
Mean Number of Laboratory Days Per Patient Year Stratified by International Metastatic Database Consortium (IMDC) Risk Category Up to maximum of 12 years (retrospective data collection of 1 month) 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.
Number of Participants Classified According to Karnofsky Performance Status (KPS) Stratified by IMDC Risk Category At index 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.
Number of Participants Classified According to Pathological Diagnosis (PAD) Histology At index 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Pfizer Finland
🇫🇮Helsinki, Finland