Clincosm LogoSign in Get a demo

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).

Sponsor
Pfizer (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05534789
Collaborator
(none)
400
Enrollment
15.5
Anticipated Duration (Months)

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated 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)
    Anticipated Study Start Date :
    Sep 15, 2022
    Anticipated Primary Completion Date :
    Dec 31, 2023
    Anticipated Study Completion Date :
    Dec 31, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Progression Free Survival [01 Jan 2020-01 July 2022]

    Secondary Outcome Measures

    1. Overall Survival (OS) [01 Jan 2020-01 July 2022]

    2. Proportion of different drug regimen [01 Jan 2020-01 July 2022]

    3. Best response rate (RR) [01 Jan 2020-01 July 2022]

    4. Duration of Response (DoR) [01 Jan 2020-01 July 2022]

    5. Time to progression (TTP) [01 Jan 2020-01 July 2022]

    6. Time to next treatment (TTNT) [01 Jan 2020-01 July 2022]

    7. Number of participants with dose modifications [01 Jan 2020-01 July 2022]

    8. Number of participants with an interim/permanent discontinuation of one or all drugs of a therapy [01 Jan 2020-01 July 2022]

    9. Number of participants continuing therapy after dose modification [01 Jan 2020-01 July 2022]

    10. Number of participants continuing therapy after temporary/permanent discontinuation of single drugs [01 Jan 2020-01 July 2022]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Pfizer

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT05534789
    Other Study ID Numbers:
    • A4061099
    First Posted:
    Sep 10, 2022
    Last Update Posted:
    Sep 10, 2022
    Last Verified:
    Sep 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Pfizer
    Real World Chart Review
    Retrospective
    Germany
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Renal Cell

    Study Results

    No Results Posted as of Sep 10, 2022