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).

May 2, 2023 updated by: Pfizer

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)

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

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10017
        • Pfizer New York

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants who received first line treatment for advanced renal call carcinoma

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression Free Survival
Time Frame: 01 Jan 2020-01 July 2022
01 Jan 2020-01 July 2022

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival (OS)
Time Frame: 01 Jan 2020-01 July 2022
01 Jan 2020-01 July 2022
Proportion of different drug regimen
Time Frame: 01 Jan 2020-01 July 2022
01 Jan 2020-01 July 2022
Best response rate (RR)
Time Frame: 01 Jan 2020-01 July 2022
01 Jan 2020-01 July 2022
Duration of Response (DoR)
Time Frame: 01 Jan 2020-01 July 2022
01 Jan 2020-01 July 2022
Time to progression (TTP)
Time Frame: 01 Jan 2020-01 July 2022
01 Jan 2020-01 July 2022
Time to next treatment (TTNT)
Time Frame: 01 Jan 2020-01 July 2022
01 Jan 2020-01 July 2022
Number of participants with dose modifications
Time Frame: 01 Jan 2020-01 July 2022
01 Jan 2020-01 July 2022
Number of participants with an interim/permanent discontinuation of one or all drugs of a therapy
Time Frame: 01 Jan 2020-01 July 2022
01 Jan 2020-01 July 2022
Number of participants continuing therapy after dose modification
Time Frame: 01 Jan 2020-01 July 2022
01 Jan 2020-01 July 2022
Number of participants continuing therapy after temporary/permanent discontinuation of single drugs
Time Frame: 01 Jan 2020-01 July 2022
01 Jan 2020-01 July 2022

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2022

Primary Completion (Anticipated)

January 30, 2024

Study Completion (Anticipated)

January 30, 2024

Study Registration Dates

First Submitted

September 6, 2022

First Submitted That Met QC Criteria

September 6, 2022

First Posted (Actual)

September 10, 2022

Study Record Updates

Last Update Posted (Actual)

May 3, 2023

Last Update Submitted That Met QC Criteria

May 2, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A4061099

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD 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/data_requests.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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