Prospective Patient Reported Outcomes (PRO) Registry in Patients With Advanced Renal Cell Carcinoma (PROKidney)
|ClinicalTrials.gov Identifier: NCT02537743|
Recruitment Status : Active, not recruiting
First Posted : September 2, 2015
Last Update Posted : June 9, 2020
|Condition or disease|
|Renal Cell Carcinoma|
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 Type :||Observational|
|Estimated Enrollment :||100 participants|
|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 :||August 19, 2015|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
- Primary Outcome Measure (Patient Reported Outcomes (PRO) regarding typical ailments in the real Life RCC population) [ Time Frame: 24 months ]Patient Reported Outcomes (PRO) regarding typical ailments in the real Life RCC population
- Secondary Outcome Measures (Patient Reported Outcomes (PRO) regarding the impact of treatment on daily life) [ Time Frame: 24 months ]Patient Reported Outcomes (PRO) regarding the impact of treatment on daily life
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02537743
|Multiple sites all over Germany|
|Multiple Locations, Germany|
|Study Chair:||Tilman Kirste, MD||medical practise for oncology|