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临床试验/NCT05363072
NCT05363072已完成不适用

Registry-based Non-interventional Analysis of Advanced/Metastatic Renal Carcinoma Treatment Patterns and Outcomes in the Hospital District of Southwest Finland.

Pfizer1 个研究点 分布在 1 个国家目标入组 1,112 人开始时间: 2022年5月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Pfizer
入组人数
1,112
试验地点
1
主要终点
Number of Participants According to Co-Diagnoses After Index

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Number of Participants According to Co-Diagnoses After Index

时间窗: 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)

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Pfizer
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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