Informations générales (source: ClinicalTrials.gov)
Heath Related Quality of Life Assessment for Patients With Advanced or Metastatic Renal Cell Carcinoma Treated With Tyrosine Kinase Inhibitor Using Electronic Patient Reported Outcome in Daily Clinical Practice. (QUANARIE)
Interventional
N/A
Centre Hospitalier Universitaire de Besancon (Voir sur ClinicalTrials)
mai 2017
février 2020
29 juin 2024
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| UNITE D HOSPITALISAT AVRON M BLANCHE | Louis-Marie Dourthe, MD | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre de lutte contre le cancer Alexis Vautrin - Institut de Cancérologie de Lorraine - 54519 - Vandœuvre-lès-Nancy - France | Lionnel Geoffrois, MD | Contact (sur clinicalTrials) | |||
| Centre de lutte contre le cancer Georges François Leclerc - 21000 - Dijon - France | Sylvain Ladoire, MD | Contact (sur clinicalTrials) | |||
| CHU de Besançon - 25030 - Besançon - France | Contact (sur clinicalTrials) | ||||
| Hôpital Nord Franche-Comté - 25200 - Montbéliard - France | Guillaume Mouillet, MD | Contact (sur clinicalTrials) | |||
| Hôpital privé Sainte Marie - 71100 - Chalon-sur-Saône - France | Erika Viel, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre de lutte contre le cancer Jean Godinot - 51100 - Reims - France | Jean-Christophe Eymard, MD | Contact (sur clinicalTrials) | |||
| Hôpitaux Universitaires de Strasbourg - 67000 - Strasbourg - France | Philippe Barthelemy, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Patient with renal clear cells carcinoma, histologically or cytologically confirmed,
locally advanced nonresectable or metastatic who initiate an oral treatment by ITK
anti-VEGF (Pazopanib or Sunitinib.)
- Estimated life expectancy over than 3 months.
- Male or female
- Aged 18 years or older
- Patient able to understand French and to complete study questionnaires (no major
cognitive disorders)
- Signed informed consent
- Patient affiliated to or beneficiary of French social security regime
- Patient with renal clear cells carcinoma, histologically or cytologically confirmed,
locally advanced nonresectable or metastatic who initiate an oral treatment by ITK
anti-VEGF (Pazopanib or Sunitinib.)
- Estimated life expectancy over than 3 months.
- Male or female
- Aged 18 years or older
- Patient able to understand French and to complete study questionnaires (no major
cognitive disorders)
- Signed informed consent
- Patient affiliated to or beneficiary of French social security regime
- Prior systemic treatment for metastatic renal cancer other than immunotherapy.
Pretreatment or concomitant treatment with Biphosphonate or Denosumab is allowed.
- Renal carcinoma without clear cell component.
- Psychiatric illness compromising understanding of the information or conducting the
study.
- Any acute or chronic disease (eg severe COPD) may affect the patient's ability to
receive treatment under study or may make it difficult the interpretation of
toxicities or adverse events.
- HIV positive.
- History of active chronic hepatitis including subjects who are carriers of Hepatitis
B virus or Hepatitis C virus
- Uncontrolled infection
- History of digestive pathology which could compromise the good absorption of an oral
ITK.
- Pregnancy, breast-feeding or absence/refusal of adequate contraception for fertile
patients during the period of treatment and for 4 months from the last treatment
administration.
- Hypersensitivity or contraindication to any of the study drugs (active substance of
ITK or any excipients.)