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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  2. Burbank, California
  3. Downey, California
  4. Glendale, California
  5. Los Angeles, California
  6. Los Angeles, California
  7. Los Angeles, California
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  9. Los Angeles, California
  10. Los Angeles, California
  11. Los Angeles, California
  12. Montebello, California
  13. West Covina, California
  14. Whittier, California
  15. Aurora, Colorado
  16. Aurora, Colorado
  17. Aurora, Colorado
  18. Boulder, Colorado
  19. Colorado Springs, Colorado
  20. Denver, Colorado
  21. Denver, Colorado
  22. Lakewood, Colorado
  23. Littleton, Colorado
  24. Lone Tree, Colorado
  25. Longmont, Colorado
  26. Parker, Colorado
  27. Thornton, Colorado
  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
  46. Sarasota, Florida
  47. Sarasota, Florida
  48. Venice, Florida
  49. Venice, Florida
  50. Atlanta, Georgia
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  52. Boise, Idaho
  53. Fruitland, Idaho
  54. Meridian, Idaho
  55. Nampa, Idaho
  56. Twin Falls, Idaho
  57. Maywood, Illinois
  58. Carmel, Indiana
  59. Fishers, Indiana
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  61. Indianapolis, Indiana
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  63. Boston, Massachusetts
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  65. Ann Arbor, Michigan
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  67. Farmington Hills, Michigan
  68. Minneapolis, Minnesota
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  70. Saint Louis, Missouri
  71. Saint Louis, Missouri
  72. Washington, Missouri
  73. Henderson, Nevada
  74. Las Vegas, Nevada
  75. Las Vegas, Nevada
  76. Las Vegas, Nevada
  77. Las Vegas, Nevada
  78. Hackensack, New Jersey
  79. Hackensack, New Jersey
  80. Hackensack, New Jersey
  81. Bronx, New York
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  84. Oneida, New York
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  88. Cary, North Carolina
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  93. Raleigh, North Carolina
  94. Cleveland, Ohio
  95. Cleveland, Ohio
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  97. Columbus, Ohio
  98. Columbus, Ohio
  99. Mayfield Heights, Ohio
  100. Mentor, Ohio
  101. Orange Village, Ohio
  102. Westlake, Ohio
  103. Eugene, Oregon
  104. Springfield, Oregon
  105. Hershey, Pennsylvania
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  107. Charleston, South Carolina
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  111. Seneca, South Carolina
  112. Spartanburg, South Carolina
  113. Chattanooga, Tennessee
  114. Chattanooga, Tennessee
  115. Franklin, Tennessee
  116. Franklin, Tennessee
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  122. Nashville, Tennessee
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  154. Leesburg, Virginia
  155. Newport News, Virginia
  156. Norfolk, Virginia
  157. Virginia Beach, Virginia
  158. Woodbridge, Virginia
  159. Seattle, Washington
  160. Seattle, Washington
  161. Seattle, Washington
  162. Garran, Australian Capital Territory
  163. Kurralta Park, South Australia
  164. Ballarat, Victoria
  165. East Melbourne, Victoria
  166. Heidelberg West, Victoria
  167. Heidelberg, Victoria
  168. Wien,
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  171. Porto Alegre, RS
  172. Barretos, SP
  173. Sao Paulo, SP
  174. Calgary, Alberta
  175. Edmonton, Alberta
  176. Kelowna, British Columbia
  177. Moncton, New Brunswick
  178. St. John's, Newfoundland and Labrador
  179. Oshawa, Ontario
  180. Beijing, Chaoyang District
  181. Nanjing, Jiangsu
  182. Beijing, P.R.
  183. Xi'an, Shaanxi
  184. Guangzhou,
  185. Shanghai,
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  227. Sapporo, Hokkaido
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  229. Osakasayama, Osaka
  230. Hamamatsu-City, Shizuoka
  231. Sunto-gun, Shizuoka
  232. Arakawa-ku, Tokyo
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  237. Ube-shi, Yamaguchi
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  245. Busan,
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  249. Seoul,
  250. Poznan, Wielkopolska
  251. Poznan, Wielkopolska
  252. Gdansk,
  253. Poznan,
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  255. Warszawa,
  256. Wroclaw,
  257. Obninsk, Kaluga Region
  258. Moscow,
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  261. Moscow,
  262. Moscow,
  263. St. Petersburg,
  264. Singapore,
  265. Bratislava,
  266. Bratislava,
  267. Zilina,
  268. L'hospitalet de Llobregat, Barcelona
  269. Pamplona, Navarra
  270. Pamplona, Navarra
  271. Barcelona,
  272. Madrid,
  273. Madrid,
  274. Malaga,
  275. Sevilla,
  276. Zaragoza,
  277. Linkoping,
  278. Umea,
  279. Vaxjo,
  280. Kaohsiung Hsien,
  281. Taichung,
  282. Taipei,
  283. Taoyuan,
  284. London, England
  285. Northwood, Middlesex
  286. Bebington, Wirral,
  287. Birmingham,
  288. Bournemouth,
  289. Bristol,
  290. Cambridge,
  291. Glasgow,
  292. London,
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  9. Ann Arbor, Michigan
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  10. Columbia, Missouri
  11. Omaha, Nebraska
  12. Henderson, Nevada
  13. Henderson, Nevada
  14. Henderson, Nevada
  15. Las Vegas, Nevada
  16. Las Vegas, Nevada
  17. Las Vegas, Nevada
  18. Morristown, New Jersey
  19. Parsippany, New Jersey
  20. Albany, New York
  21. Albany, New York
  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
  34. Charleston, South Carolina
  35. Amarillo, Texas
  36. Beaumont, Texas
  37. Bedford, Texas
  38. Dallas, Texas
  39. Fort Worth, Texas
  40. Fort Worth, Texas
  41. Fort Worth, Texas
  42. Fort Worth, Texas
  43. Grapevine, Texas
  44. Kerrville, Texas
  45. McAllen, Texas
  46. Midland, Texas
  47. San Antonio, Texas
  48. San Antonio, Texas
  49. Webster, Texas
  50. Weslaco, Texas
  51. Christiansburg, Virginia
  52. Low Moor, Virginia
  53. Roanoke, Virginia
  54. Salem, Virginia
  55. Wytheville, Virginia
  56. Vancouver, Washington
  57. Vancouver, Washington
  58. Wenatchee, Washington
  59. Banja Luka,
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  62. Sofia,
  63. Varna,
  64. Temuco, Cautin
  65. Temuco, IX Region
  66. Providencia, Santiago
  67. Santiago,
  68. Beijing, Beijing
  69. Haidian District, Beijing
  70. Fuzhou, Fujian
  71. Guangzhou, Guang DONG
  72. Guangzhou, Guangdong
  73. Nanjing, Jiangsu
  74. Nanjing, Jiangsu
  75. Changchun, Jilin
  76. Shen Yang, LIAO NING
  77. Xi'an, Shaanxi
  78. Shanghai, Shanghai
  79. Chengdu, Sichuan
  80. Hangzhou, Zhejiang
  81. Beijing,
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  84. Nanjing,
  85. Shanghai,
  86. Tianjin,
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  88. Hyderabad, Andhra Pradesh
  89. Bangalore, Karnataka
  90. Bangalore, Karnataka
  91. Bangalore, Karnataka
  92. Nagpur, Maharashtra
  93. Nashik, Maharashtra
  94. Nashik, Maharashtra
  95. Pune, Maharashtra
  96. Pune, Maharashtra
  97. Bangalore,
  98. Kuala Lumpur,
  99. Mexico, DF
  100. Mexico City, Distrito Federal
  101. Toluca, Estado DE Mexico
  102. Aguascalientes,
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  105. Quezon City, Metro Manila
  106. Quezon City, Metro Manila
  107. Makati City,
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  110. Cluj-Napoca,
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  114. Ryazan,
  115. Ryazan,
  116. Saint-Petersburg,
  117. Ufa,
  118. Port Elizabeth,
  119. Taichung,
  120. Taipei,
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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 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 No
Contacts
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
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 March 2021