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

NCT05363072 | Completed Results

• 2 other identifiers: A4061098FIN-RCC-RWD
• Study Type: observational
• Target: 1,112
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (13)

• 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

Other Outcomes (4)

• Overall Survival

  From index until death due to any cause or end of study (maximum up to 12 years)

• Time to Next Treatment (TTNT)

  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

  At index

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Finland

Helsinki, 00330, Finland

Location

Related Publications (1)

• 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.

  PMID: 37941979 DERIVED

Related Links

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

MeSH Terms

Conditions

Carcinoma, Renal Cell; Kidney Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2022
• First Posted: May 5, 2022
• Study Start: May 2, 2022
• Primary Completion: June 8, 2022
• Study Completion: June 8, 2022
• Last Updated: October 1, 2024
• Results First Posted: October 1, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)