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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).

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05534789
Recruitment Status : Active, not recruiting
First Posted : September 10, 2022
Last Update Posted : May 3, 2023
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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Brief 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


Condition or disease
Carcinoma, Renal Cell

Study Design
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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Retrospective
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)
Actual Study Start Date : October 15, 2022
Estimated Primary Completion Date : January 30, 2024
Estimated Study Completion Date : January 30, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 01 Jan 2020-01 July 2022 ]

Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: 01 Jan 2020-01 July 2022 ]
  2. Proportion of different drug regimen [ Time Frame: 01 Jan 2020-01 July 2022 ]
  3. Best response rate (RR) [ Time Frame: 01 Jan 2020-01 July 2022 ]
  4. Duration of Response (DoR) [ Time Frame: 01 Jan 2020-01 July 2022 ]
  5. Time to progression (TTP) [ Time Frame: 01 Jan 2020-01 July 2022 ]
  6. Time to next treatment (TTNT) [ Time Frame: 01 Jan 2020-01 July 2022 ]
  7. Number of participants with dose modifications [ Time Frame: 01 Jan 2020-01 July 2022 ]
  8. Number of participants with an interim/permanent discontinuation of one or all drugs of a therapy [ Time Frame: 01 Jan 2020-01 July 2022 ]
  9. Number of participants continuing therapy after dose modification [ Time Frame: 01 Jan 2020-01 July 2022 ]
  10. Number of participants continuing therapy after temporary/permanent discontinuation of single drugs [ Time Frame: 01 Jan 2020-01 July 2022 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants who received first line treatment for advanced renal call carcinoma
Criteria

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:

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05534789


Locations
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United States, New York
Pfizer New York
New York, New York, United States, 10017
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT05534789    
Other Study ID Numbers: A4061099
First Posted: September 10, 2022    Key Record Dates
Last Update Posted: May 3, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.
Keywords provided by Pfizer:
Real World Chart Review
Retrospective
Germany
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
 Urogenital Neoplasms
Neoplasms by Site
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Kidney Diseases
Urologic Diseases
Male Urogenital Diseases