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

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ClinicalTrials.gov Identifier: NCT02537743
Recruitment Status : Active, not recruiting
First Posted : September 2, 2015
Last Update Posted : June 9, 2020
Sponsor:
Information provided by (Responsible Party):
iOMEDICO AG

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

Condition or disease
Renal Cell Carcinoma

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.

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Study Type : Observational
Estimated Enrollment : 100 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 : August 19, 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020





Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02537743


Locations
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Germany
Multiple sites all over Germany
Multiple Locations, Germany
Sponsors and Collaborators
iOMEDICO AG
Investigators
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Study Chair: Tilman Kirste, MD medical practise for oncology
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Responsible Party: iOMEDICO AG
ClinicalTrials.gov Identifier: NCT02537743    
Other Study ID Numbers: IOM - 04302
First Posted: September 2, 2015    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by iOMEDICO AG:
Patient Reported Outcomes
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases