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PROKidney: Prospective Patient Reported Outcomes (PRO) Registry in Patients With Advanced Renal Cell Carcinoma

Sponsor
iOMEDICO AG (Industry)
Overall Status
Completed
CT.gov ID
NCT02537743
Collaborator
(none)
98
Enrollment
1
Location
66.1
Actual Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Evaluation of patient reported outcomes ( PRO) regarding typical ailments in the REAL LIFE Renal Cell Carcinoma population

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The PRO Kidney project will recruit a representative cohort of patients with advanced renal cell carcinoma (RCC) treated with systemic antiproliferative therapies such as TKIs, mTOR inhibitors, cytokines, antiVEGF or immune therapy. The aim of this study is to collect data on the effectiveness and patients´quality of life on preference in the real life setting.

    Patient Reported Outcomes ( PRO) are assessed by a questionnaire consisting Functional Assessment of Cancer Therapy ( FACT) Kidney Syndrome Index 19 (FKSI 19) completed by four questions assessing ailments about changes in skin of hands/feet, taste, color of hair and mouth scores.

    13 Questions about Fatigue assessed with the Functional Assessment of Chronic IIlness Disease.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    98 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Open-labeled, Multicenter, Non-interventional, Prospective PRO Registry for Patients With First Line Treatment for Advanced RCC Using a Tablet-technology Based Digital Device
    Actual Study Start Date :
    Aug 19, 2015
    Actual Primary Completion Date :
    Feb 19, 2021
    Actual Study Completion Date :
    Feb 19, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Primary Outcome Measure (Patient Reported Outcomes (PRO) regarding typical ailments in the real Life RCC population) [24 months]

      Patient Reported Outcomes (PRO) regarding typical ailments in the real Life RCC population

    Secondary Outcome Measures

    1. Secondary Outcome Measures (Patient Reported Outcomes (PRO) regarding the impact of treatment on daily life) [24 months]

      Patient Reported Outcomes (PRO) regarding the impact of treatment on daily life

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Histologically confirmed renal cell carcinoma

    • Start of the first line systemic treatment

    • Ability to read and understand German

    • Written informed consent

    Exclusion Criteria:
    • None

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Multiple sites all over Germany Multiple Locations Germany

    Sponsors and Collaborators

    • iOMEDICO AG

    Investigators

    • Study Chair: Tilman Kirste, MD, medical practise for oncology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    iOMEDICO AG
    ClinicalTrials.gov Identifier:
    NCT02537743
    Other Study ID Numbers:
    • IOM - 04302
    First Posted:
    Sep 2, 2015
    Last Update Posted:
    Mar 25, 2021
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by iOMEDICO AG
    Patient Reported Outcomes
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Renal Cell

    Study Results

    No Results Posted as of Mar 25, 2021