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NCT05534789 Clinical Trial

Treatment Patterns and Clinical Outcomes Among Patients With Advanced Renal Cell Carcinoma (aRCC) Receiving Systemic First-line (1st Line) Anti-cancer Treatment Under Daily Routine in Germany: Retrospective Medical Chart Review (RENALISTIC Study).

Carcinoma, Renal Cell Clinical Trial

Official title:
Clinical Outcomes and Therapy Management Among Patients With Advanced Renal Cell Carcinoma (aRCC) Receiving Systemic First-line (1L) Anti-cancer Treatment Under Daily Routine in Germany: Retrospective Chart Review (RENALISTIC Study)

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05534789
Other study ID # A4061099
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date October 15, 2022
Est. completion date January 30, 2024

Study information
Verified date May 2023
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to learn about the treatments used in for advanced renal cell carcinoma as well as effectiveness of these treatments in the real world. Study participants must be: At least 18 years of age or older. Confirmed renal cell carcinoma Received first line treatment

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 400
Est. completion date January 30, 2024
Est. primary completion date January 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Participants diagnosed with locally advanced or metastatic renal cell carcinoma - Participants with full medical information is available regarding all treatments before, during and after 1st line Exclusion Criteria:

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Pfizer New York 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 Progression Free Survival 01 Jan 2020-01 July 2022
Secondary Overall Survival (OS) 01 Jan 2020-01 July 2022
Secondary Proportion of different drug regimen 01 Jan 2020-01 July 2022
Secondary Best response rate (RR) 01 Jan 2020-01 July 2022
Secondary Duration of Response (DoR) 01 Jan 2020-01 July 2022
Secondary Time to progression (TTP) 01 Jan 2020-01 July 2022
Secondary Time to next treatment (TTNT) 01 Jan 2020-01 July 2022
Secondary Number of participants with dose modifications 01 Jan 2020-01 July 2022
Secondary Number of participants with an interim/permanent discontinuation of one or all drugs of a therapy 01 Jan 2020-01 July 2022
Secondary Number of participants continuing therapy after dose modification 01 Jan 2020-01 July 2022
Secondary Number of participants continuing therapy after temporary/permanent discontinuation of single drugs 01 Jan 2020-01 July 2022
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