Study of Patients With Metastatic and/or Advanced Renal Cell Carcinoma, Treated With Sunitinib/Axitinib.
NCT04033991
ABOUT THIS STUDY
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1. Over the age of 18 years
2. Diagnosis of renal cell carcinoma
3. Treatment with sunitinib and/or axitinib
4. Timeframe: from database inception date (2002) until the end of June 2017.
Patients meeting any of the following criteria will not be included in the study:
1. Under the age of 18 years
2. Diagnosis other than renal cell carcinoma
3. No treatment with sunitinib and/or axitinib
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Descriptive Information | |||||||
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Brief Title | Study of Patients With Metastatic and/or Advanced Renal Cell Carcinoma, Treated With Sunitinib/Axitinib. | ||||||
Official Title | A Real World Retrospective Database Study of Patients Diagnosed With Metastatic and/or Advanced Renal Cell Carcinoma and Treated With Sunitinib and/or Axitinib in a Specialist United Kingdom Oncology Centre | ||||||
Brief Summary | Research Questions: To understand the clinical outcomes of patients treated with sunitinib in first line and axitinib in second line in a real world setting as therapies for metastatic and/or advanced renal cell carcinoma (mRCC). Primary Objective:
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Detailed Description | Research Questions: To understand the clinical outcomes of patients treated with sunitinib in first line and axitinib in second line in a real world setting as therapies for metastatic and/or advanced renal cell carcinoma (mRCC). Primary Objective:
Secondary Objectives: First Line:
Second line:
The objectives listed below will also be assessed as exploratory analyses for various patient subgroups of interest, and will be conducted if sufficient numbers of patients are available:
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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 |
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Condition |
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Intervention |
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Study Groups/Cohorts | Patients with advanced RCC
Patients with a diagnosis of kidney cancer (renal cell carcinoma, advanced or metastatic) Interventions:
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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 | Completed | ||||||
Actual Enrollment | 1 | ||||||
Original Estimated Enrollment | 841 | ||||||
Actual Study Completion Date | December 18, 2020 | ||||||
Actual Primary Completion Date | May 31, 2020 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria | Inclusion criteria
Exclusion criteria Patients meeting any of the following criteria will not be included in the study:
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Sex/Gender |
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Ages | Child, Adult, Older Adult | ||||||
Accepts Healthy Volunteers | No | ||||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries | United Kingdom | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number | NCT04033991 | ||||||
Other Study ID Numbers | X9001180 | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | Pfizer | ||||||
Study Sponsor | Pfizer | ||||||
Collaborators | Not Provided | ||||||
Investigators |
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PRS Account | Pfizer | ||||||
Verification Date | January 2021 |