Treatment Patterns With Targeted Therapies In Mrcc In Sweden - A Retrospective Analysis Of Data From National Registries
NCT04669366
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1. all patients aged ≥ 18 years with at least one filled prescription of an oral targeted therapy relevant for treating mRCC registered in the Swedish Prescribed Drug Register (PDR) between July 1st 2005 and June 30th 2020. The Anatomical Therapeutic Chemical (ATC) codes for the oral drugs relevant for treating mRCC are the following: L01XE04 (sunitinib), L01XE05 (sorafenib), L01XE11 (pazopanib), L01XE17 (axitinib), L01XE10 (everolimus), L01XE26 (cabozantinib), L01XE34 (tivozantib), L01XE29 (lenvatinib).
2. The patients identified in the PDR that also are identified in the SCR with the International Classification of Diseases and Related Health Problems (ICD)-7 diagnosis codes I800 or I809 and ICD-10 codes C64.0 and C64.9 from January 1st 2000 until December 31st 2019;excluding ICD-7 code I801 (cancer of the renal pelvis) will be included in the analysis set.
Patients with ICD-7 code I801 will be excluded
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Descriptive Information | |||||
---|---|---|---|---|---|
Brief Title | Treatment Patterns With Targeted Therapies In Mrcc In Sweden - A Retrospective Analysis Of Data From National Registries | ||||
Official Title | TREATMENT PATTERNS WITH TARGETED THERAPIES IN METASTATIC RENAL CELL CARCINOMA (MRCC) IN SWEDEN - A RETROSPECTIVE ANALYSIS OF DATA FROM NATIONAL REGISTRIES | ||||
Brief Summary | The objectives of this study is to investigate treatment patterns and outcomes for Sutent and Inlyta in mRCC patients in a nationwide population-based setting in Sweden. | ||||
Detailed Description | Not Provided | ||||
Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Retrospective | ||||
Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Non-Probability Sample | ||||
Study Population | The data used for the analyses includes all patients aged ? 18 years with at least one filled prescription of an oral targeted therapy relevant for treating mRCC registered in the Swedish Prescribed Drug Register between July 1st 2005 (there is no data available in the register before this date) and June 30th 2020. The Anatomical Therapeutic Chemical (ATC) codes for the oral drugs relevant for treating mRCC are the following: L01XE04 (sunitinib), L01XE05 (sorafenib), L01XE11 (pazopanib), L01XE17 (axitinib), L01XE10 (everolimus), L01XE26 (cabozantinib), L01XE34 (tivozantib), L01XE29 (lenvatinib). The patients identified in the PDR that also are identified in the SCR with the International Classification of Diseases and Related Health Problems (ICD)-7 diagnosis codes I800 or I809 and ICD-10 codes C64.0 and C64.9 from January 1st 2000 until December 31st 2019;excluding ICD-7 code I801 (cancer of the renal pelvis) will be included in the analysis set. | ||||
Condition | Kidney Neoplasms | ||||
Intervention |
| ||||
Study Groups/Cohorts | Patients in Sweden with metastatic renal cell carcinoma
The cohort of patients with metastatic renal cell carcinoma in Sweden Interventions:
| ||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
Recruitment Information | |||||
Recruitment Status | Not yet recruiting | ||||
Estimated Enrollment | 1000 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | March 31, 2021 | ||||
Estimated Primary Completion Date | March 31, 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria: Patients with ICD-7 code I801 will be excluded | ||||
Sex/Gender |
| ||||
Ages | 18 Years to 99 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | Not Provided | ||||
Contacts |
| ||||
Listed Location Countries | Sweden | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT04669366 | ||||
Other Study ID Numbers | A6181234 RENCOMP3 ( Other Identifier: Alias Study Number ) | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement |
| ||||
Responsible Party | Pfizer | ||||
Study Sponsor | Pfizer | ||||
Collaborators | Not Provided | ||||
Investigators |
| ||||
PRS Account | Pfizer | ||||
Verification Date | December 2020 |