NCT03062410: QUANARIE

Quality of Life Assessment in Daily Clinical Oncology Practice for Patients With Advanced Renal Cell Carcinoma

Status unknown NA Last updated 26 July 2018

What this trial tests

NA trial testing Electronic PRO in daily clinical practice in Renal Carcinoma Metastatic in 56 participants. Status unknown.

Timeline

4 May 2017

Primary endpoint
4 November 2019

4 February 2020

Quick facts

Lead sponsor	Centre Hospitalier Universitaire de Besancon
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	56
Start date	4 May 2017
Primary completion	4 November 2019
Estimated completion	4 February 2020
Sites	8 locations across France

Drugs / interventions tested

• Electronic PRO in daily clinical practice

Conditions studied

• Renal Carcinoma Metastatic — all drugs for Renal Carcinoma Metastatic →
• Kidney Neoplasms — all drugs for Kidney Neoplasms →
• Renal Cancer — all drugs for Renal Cancer →

Sponsor

Centre Hospitalier Universitaire de Besancon

Who can join

18 and older, any sex, with Renal Carcinoma Metastatic or Kidney Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Physician mainly use RECIST progression-free survival (PFS) and NCI CTCAE safety as a guide to evaluate treatment efficiency. In contrast Health Related Quality of Life (HRQOL) assessment is often restricted to clinical trial. It could be of particular interest to evaluate HRQOL in daily clinical practice in order to adequately choose and manage first line therapy, especially since HRQOL at diagnosis was shown to be a prognostic factor of overall survival in advanced or metastatic renal cell carcinoma (mRCC). A systematic collection in daily clinical practice of the HRQoL data using standardized questionnaires could strengthen management of symptoms : improve symptom control, improve patient-clinician communication, satisfaction with care and well-being of the patient and in fine the overall survival.

The objective of the QUANARIE Study is to assess the use of HRQOL assessment in daily clinical practice for patients with mRCC treated with tyrosine kinase inhibitor (TKI) using electronic patient reported outcome (PRO).

Indeed, the goal is to make the HRQoL data accessible and exploitable in real time to clinicians, to help medical professionals to optimize their practices by adopting a holistic and personalized approach based on patient reported outcomet.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Drug-Induced Hypertension Caused by Multikinase Inhibitors (Sorafenib, Sunitinib, Lenvatinib and Axitinib) in Renal Cell Carcinoma Treatment.
   Bæk Møller N, Budolfsen C, Grimm D, Krüger M, et al · · 2019 · cited 43× · PMID 31547602 · DOI 10.3390/ijms20194712
2. Health-related quality of life assessment for patients with advanced or metastatic renal cell carcinoma treated with a tyrosine kinase inhibitor using electronic patient-reported outcomes in daily clinical practice (QUANARIE trial): study protocol.
   Mouillet G, Fritzsch J, Paget-Bailly S, Pozet A, et al · · 2019 · cited 6× · PMID 30717745 · DOI 10.1186/s12955-019-1085-1
3. 27th Annual Conference of the International Society for Quality of Life Research.
   · 2020 · cited 3× · PMID 33068237 · DOI 10.1007/s11136-020-02626-y