Master Protocol to Study Treatment Patterns, Medication Adherence, Health and Economic Outcomes and Unmet Needs in RCC

Study Overview
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Brief Summary
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The study aims to assess treatment patterns and outcomes in advanced RCC patients in real world clinical practices across various real world databases. Four databases will be evaluated

Official Title
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Study of Advanced Renal Cell Carcinoma Treatment Patterns and Unmet Needs Using Real World Claims and Electronic Medical Record Data.

Conditions
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Renal Cell Carcinoma (RCC)

Intervention / Treatment
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* Drug: Tyrosine kinase inhibitor (TKI)
* Drug: Immuno-oncology (IO)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 20 years or older in the year of the index first line therapy prescription. 2 or more RCC diagnoses (ICD-9: 189.0; ICD-10: C64.1, C64.2, C64.9) at least 30 days apart, in the 1 year prior to the index date until 30 days post index date. 2 or more code for secondary malignancy codes indicating possible diagnoses for metastatic disease at least 30 days apart, in the 1 year prior to the index date until 30 days post index date. (ICD-9: xx-199.xx; ICD-10: C77-C79, except ICD9: 198.0 Secondary malignant neoplasm of the kidney and ICD10: C79.0 Secondary malignant neoplasm of the kidney and renal pelvis.) Exploratory sensitivity analyses were performed to review patients with 1 or more diagnosis codes for advanced or metastatic RCC 12 months prior to the index date and 1 or more secondary malignancy codes around the RCC diagnosis dates. Continuous enrollment from 12 months prior to the index date. Patients will be required to have continuous enrollment from their index date until the end of the available data. This will allow for sub-analysis of cohorts with 3 months, 6 months and 12 months of available data Exclusion Criteria: Received advanced treatment prior to the study index date. Prescription records with negative days of supply will be excluded from all the analyses except in cost variable calculation. The day of supply for claims with missing or 0 days will be imputed. Only one RCC diagnosis in the 12 months prior or one mont post index date. Patients with data for analysis (< 3 months post index date)

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with advanced renal cell carcinoma (RCC)<br> | Drug: Tyrosine kinase inhibitor (TKI)<br>* TKIs<br>Drug: Immuno-oncology (IO)<br>* IOs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patient with specific demographics and clinical characteristics |  | April 2018-March 2021 | 
| To describe select outcomes of interest among the following1st line treated cohorts of interest: |  | April 2018-March 2021 | 
| Percentage of patients within treatment patterns, and survival |  | April 2018-March 2021 |