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

March 24, 2021 updated by: iOMEDICO AG

Open-labeled, Multicenter, Non-interventional, Prospective PRO Registry for Patients With First Line Treatment for Advanced RCC Using a Tablet-technology Based Digital Device

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

98

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Multiple Locations, Germany
        • Multiple sites all over germany

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient with advanced (inoperable or metastatic) renal cell cancer at the start of the first line antitumoral therapy

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

iOMEDICO AG

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 19, 2015

Primary Completion (Actual)

February 19, 2021

Study Completion (Actual)

February 19, 2021

Study Registration Dates

First Submitted

August 26, 2015

First Submitted That Met QC Criteria

August 28, 2015

First Posted (Estimate)

September 2, 2015

Study Record Updates

Last Update Posted (Actual)

March 25, 2021

Last Update Submitted That Met QC Criteria

March 24, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IOM - 04302

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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