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

NCT ID: NCT02537743

Last Updated: 2021-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

98 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-08-19

Study Completion Date

2021-02-19

Brief Summary

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

Detailed Description

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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.

Conditions

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Renal Cell Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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iOMEDICO AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tilman Kirste, MD

Role: STUDY_CHAIR

medical practise for oncology

Locations

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Multiple sites all over Germany

Multiple Locations, , Germany

Site Status

Countries

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Germany

Other Identifiers

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IOM - 04302

Identifier Type: -

Identifier Source: org_study_id

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