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Completed

NCT Number: NCT02537743

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

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

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Key information

Conditions

Renal Cell Carcinoma Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiple sites all over Germany

Multiple Locations, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

iOMEDICO AG

Industry

Registry information

Official study 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

Acronym: PROKidney

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Sep 2, 2015
Registry last updated
Mar 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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