Treatment Patterns With Targeted Therapies In Mrcc In Sweden - A Retrospective Analysis Of Data From National Registries

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NCT04669366

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Study Location
Pfizer Innovations AB
Sollentuna, , 19190, Sweden
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Kidney Neoplasms
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-99 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


Patients with ICD-7 code I801 will be excluded

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Kidney NeoplasmsTreatment Patterns With Targeted Therapies In Mrcc In Sweden - A Retrospective Analysis Of Data From National Registries
NCT04669366
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  12. Montebello, California
  13. West Covina, California
  14. Whittier, California
  15. Aurora, Colorado
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  23. Littleton, Colorado
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  28. Washington, District of Columbia
  29. Washington, District of Columbia
  30. Bonita Springs, Florida
  31. Bradenton, Florida
  32. Cape Coral, Florida
  33. Cape Coral, Florida
  34. Deerfield Beach, Florida
  35. Englewood, Florida
  36. Fort Myers, Florida
  37. Fort Myers, Florida
  38. Fort Myers, Florida
  39. Fort Myers, Florida
  40. Miami, Florida
  41. Naples, Florida
  42. Naples, Florida
  43. Orlando, Florida
  44. Orlando, Florida
  45. Port Charlotte, Florida
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  52. Boise, Idaho
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  73. Henderson, Nevada
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  79. Hackensack, New Jersey
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  81. Bronx, New York
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  179. Oshawa, Ontario
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  252. Gdansk,
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  280. Kaohsiung Hsien,
  281. Taichung,
  282. Taipei,
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  285. Northwood, Middlesex
  286. Bebington, Wirral,
  287. Birmingham,
  288. Bournemouth,
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  19. Parsippany, New Jersey
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  22. Latham, New York
  23. Rexford, New York
  24. Troy, New York
  25. Cary, North Carolina
  26. Raleigh, North Carolina
  27. Raleigh, North Carolina
  28. Portland, Oregon
  29. Portland, Oregon
  30. Portland, Oregon
  31. Tualatin, Oregon
  32. Hershey, Pennsylvania
  33. Charleston, South Carolina
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  35. Amarillo, Texas
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  38. Dallas, Texas
  39. Fort Worth, Texas
  40. Fort Worth, Texas
  41. Fort Worth, Texas
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  44. Kerrville, Texas
  45. McAllen, Texas
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  50. Weslaco, Texas
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  53. Roanoke, Virginia
  54. Salem, Virginia
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  58. Wenatchee, Washington
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Advanced Information
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
  • Drug: sunitinib
    As provided in real world
    Other Name: Sutent
  • Drug: axitinib
    As provided in real world
    Other Name: Inlyta
Study Groups/Cohorts Patients in Sweden with metastatic renal cell carcinoma
The cohort of patients with metastatic renal cell carcinoma in Sweden
Interventions:
  • Drug: sunitinib
  • Drug: axitinib
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
 (submitted: December 9, 2020)		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:

  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.

Exclusion Criteria:

Patients with ICD-7 code I801 will be excluded

Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]zer.com
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
Plan to Share IPD:No
Plan Description: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/d….
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2020