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

Renal Cell Carcinoma (RCC) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04375150
• Other study ID #: A6181232
• Status: Completed
• Start date: December 2, 2019
• Est. completion date: October 28, 2022

Study information

• Verified date: April 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: October 28, 2022
• Est. primary completion date: October 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma (RCC)

Intervention

Drug:
• Tyrosine kinase inhibitor (TKI)
TKIs
• Immuno-oncology (IO)
IOs

Locations

Country	Name	City	State
United States	Pfizer INC	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   To obtain contact information for a study center near you, click here.