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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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.

Finland1 site

Pfizer Finland
Helsinki, 00330

Other trials in Finland

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.

2 May 20228 Jun 2022

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Renal Cell Cancer trials

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

Results posted to the registry on 1 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Participants With RCC	1,112	1,112

Primary outcome: Number of Participants According to Co-Diagnoses Before Index

Time frame: 3 years prior to index date. Count of participants. Unit: Participants

Measure	All Participants With RCC n = 191
Infection	139
D41 Neoplasm of uncertain or unknown behavior of urinary organs	45
I10 Essential (primary) hypertension	41
R91 Abnormal findings on diagnostic imaging of lung	26
R31 Unspecified hematuria	22
E11 Non-insulin-dependent diabetes mellitus	17
E78 Disorders of lipoprotein metabolism and other lipidaemias	16
I48 Atrial fibrillation and flutter	14

Population analysed: All eligible advanced/metastatic RCC participants who initiated treatment for mRCC were included. This analysis was planned only in the treated mRCC participants.

Primary outcome: Number of Participants According to Co-Diagnoses After Index

Time frame: Up to 3 years after index date. Count of participants. Unit: Participants

Measure	All Participants With RCC n = 191
Infection	144
I10 Essential (primary) hypertension	32
J18 Pneumonia, organism unspecified	28
R50 Fever of other and unknown origin	28
E11 Non-insulin-dependent diabetes mellitus	15
R10 Abdominal and pelvic pain	15
D41 Neoplasm of uncertain or unknown behavior of urinary organs	14
F43 Reaction to severe stress, and adjustment disorders	14

Population analysed: All eligible advanced/metastatic RCC participants who initiated treatment for mRCC were included. This analysis was planned only in the treated mRCC participants.

Primary outcome: Body Mass Index (BMI)

Time frame: At index. Mean (Standard Deviation). Unit: Kilogram per meter square

Measure	All Participants With RCC n = 1112
All RCC participants	27.3 (5.3)
Treated mRCC participants	25.1 (4.3)
Not-treated mRCC participants	26.5 (5.9)

Population analysed: All eligible participants were included. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.

Primary outcome: Mean Outpatient Visits and Emergent Room Visits Per Patient Year

Time frame: Up to maximum of 12 years (retrospective data collection of 1 month). Mean (95% Confidence Interval). Unit: Visits per patient year

Measure	Treated mRCC Participants n = 191
Outpatient visits: All contacts	29.37 (26.46 to 32.64)
Outpatient visits: Disease-specific	19.29 (17.36 to 21.52)
Outpatient visits: Other contacts	10.07 (8.13 to 12.3)
ER visits: All contacts	0.28 (0.19 to 0.38)
ER visits: Disease-specific	0.15 (0.09 to 0.21)
ER visits: Other contacts	0.14 (0.08 to 0.2)

Population analysed: All eligible advanced/metastatic RCC participants who initiated treatment for mRCC were included.

Adverse events

Time frame: For all-cause mortality: From index until death due to any cause or end of study (maximum up to 12 years); For adverse events: not applicable as adverse events were not collected during the study.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treated mRCC Participants	0 of 0	0 of 0	100 of 191

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.