Renal Cell CancerNCT05363072
A Study to Describe the Kidney Cancer Patient Population Treatment, and Results in the Hospital District of Southwest Finland.
An observational study of Renal Cell Cancer and Renal Cell Carcinoma, run by Pfizer at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Cancer, Renal Cell Carcinoma, Cancer of Kidney
- How many people
- 1,112 participants
- Where
- 1 siteFinland
- Study dates
- 2 May 2022to 8 Jun 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with advanced/metastatic RCC and medical records available at the in the Hospital District of Southwest Finland (HDSF) HDSF registry
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Renal Cell Cancer, Renal Cell Carcinoma, Cancer of Kidney, Cancer of the Kidney, Kidney Cancer, Kidney Neoplasms
- Keywords
- Advanced/ metastatic RCC (mRCC), Real World Evidence, Registry based study, Non-interventional study, Axitinib, Sunitinib, Pazopanib, Cabozantinib, Nivolumab, Sorafenib, Everolimus, Ipilimumab
- Medical subject headings
- Carcinoma, Renal Cell, Kidney Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At index
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start2 May 2022
- Primary completion8 Jun 2022
- Study completion8 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal Cell CancerStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 1,112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05363072
- Sponsor's protocol ID
- A4061098
- Other IDs
- FIN-RCC-RWD
- Status last verified
- Jun 2024
- First submitted
- 2 May 2022
- Last updated
- 1 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- No: 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.
Publications
Holsa O, Teittinen K, Anttalainen A, Ukkola-Vuoti L, Summanen M, Mattila KE. Observational study on the evolution of systemic treatments for advanced renal cell carcinoma in Southwest Finland between 2010 and 2021. Ther Adv Urol. 2023 Nov 5;15:17562872231206243. doi: 10.1177/17562872231206243. eCollection 2023 Jan-Dec.
PubMed 37941979
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry-based Non-interventional Analysis of Advanced/Metastatic Renal Carcinoma Treatment Patterns and Outcomes in the Hospital District of Southwest Finland.
- ClinicalTrials.gov ID
- NCT05363072
- Acronym / sponsor ID
- A4061098
- Conditions
- Renal Cell Cancer, Renal Cell Carcinoma, Cancer of Kidney, Cancer of the Kidney, Kidney Cancer, Kidney Neoplasms
- Keywords
- Advanced/ metastatic RCC (mRCC), Real World Evidence, Registry based study, Non-interventional study, Axitinib, Sunitinib, Pazopanib, Cabozantinib
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,112 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 2 May 2022 (actual)
- Primary completion
- 8 Jun 2022 (actual)
- Study completion
- 8 Jun 2022 (actual)
- First posted
- 5 May 2022 (actual)
- Results
- Posted 1 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with advanced/metastatic RCC and medical records available at the in the Hospital District of Southwest Finland (HDSF) HDSF registry
Key inclusion criteria (7 listed)
- Diagnosis of renal cell carcinoma (International Classification of Diseases 10th revision [ICD]-10:64) during 01 January 2010 and 31 December 2021
- 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
Key exclusion criteria (6 listed)
- 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
- Prevalent patients with mRCC (i.e. diagnosis of metastatic RCC before 01 January 2010)
- Patients without treatment for mRCC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants According to Co-Diagnoses Before Index
Time frame: 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.
Number of Participants According to Co-Diagnoses After Index
Time frame: 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)
Time frame: 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
Time frame: 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.
Mean Number of Hospitalizations Per Patient Year
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37941979Holsa O, Teittinen K, Anttalainen A, Ukkola-Vuoti L, Summanen M, Mattila KE. Observational study on the evolution of systemic treatments for advanced renal cell carcinoma in Southwest Finland between 2010 and 2021. Ther Adv Urol. 2023 Nov 5;15:17562872231206243. doi: 10.1177/17562872231206243. eCollection 2023 Jan-Dec.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Cell Cancer and Renal Cell Carcinoma, run by Pfizer at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants According to Co-Diagnoses Before Index (time frame: 3 years prior to index date). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05363072, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.