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NCT02537743 Clinical Trial

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

Renal Cell Carcinoma Clinical Trial

— PROKidney  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02537743
Other study ID # IOM - 04302
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 19, 2015
Est. completion date February 19, 2021

Study information
Verified date March 2021
Source iOMEDICO AG
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 98
Est. completion date February 19, 2021
Est. primary completion date February 19, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Multiple sites all over Germany Multiple Locations

Sponsors (1)
Lead Sponsor Collaborator
iOMEDICO AG

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Primary Outcome Measure (Patient Reported Outcomes (PRO) regarding typical ailments in the real Life RCC population) Patient Reported Outcomes (PRO) regarding typical ailments in the real Life RCC population 24 months
Secondary Secondary Outcome Measures (Patient Reported Outcomes (PRO) regarding the impact of treatment on daily life) Patient Reported Outcomes (PRO) regarding the impact of treatment on daily life 24 months
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