Renal Carcinoma MetastaticQUANARIENCT03062410
Quality of Life Assessment in Daily Clinical Oncology Practice for Patients With Advanced Renal Cell Carcinoma
A study testing Electronic PRO in daily clinical practice in people with Renal Carcinoma Metastatic and Kidney Neoplasms, run by Centre Hospitalier Universitaire de Besancon at 8 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Carcinoma Metastatic, Kidney Neoplasms, Renal Cancer
- What is being tested?
- Electronic PRO in daily clinical practice
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 8 sitesFrance
- Study dates
- 4 May 2017to 4 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.)
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites, 7 recruiting
- Active, not recruiting
CHU de Besançon
Besançon, 25030
- Recruiting
Hôpital privé Sainte Marie
Chalon-sur-Saône, 71100
Erika Viel, MD, 0033385488989
- Recruiting
Centre de lutte contre le cancer Georges François Leclerc
Dijon, 21000
Sylvain Ladoire, MD, 0033380737506, sladoire@cgfl.fr
- Recruiting
Hôpital Nord Franche-Comté
Montbéliard, 25200
Guillaume Mouillet, MD, mouillet.guillaume@gmail.com
- Recruiting
Centre de lutte contre le cancer Jean Godinot
Reims, 51100
Jean-Christophe Eymard, MD
- Recruiting
Groupe hospitaliser St-Vincent
Strasbourg, 67000
Louis-Marie Dourthe, MD, lm.dourthe@solcrr.org
- Recruiting
Hôpitaux Universitaires de Strasbourg
Strasbourg, 67000
Philippe Barthelemy, MD, philippe.barthelemy@chru-strasbourg.fr
- Recruiting
Centre de lutte contre le cancer Alexis Vautrin - Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, 54519
Lionnel Geoffrois, MD, l.geoffrois@nancy.unicancer.fr
About this study
Official title: 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.
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.
Read the detailed description
QUANARIE study is an interventional, prospective, multicenter trial involving 9 french oncological centers. Patients diagnosed with mRCC initiating TKI anti-VEGF treatment (Sunitinib or Pazopanib) will be invited to complete the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 cancer specific questionnaire and the EQ-5D before each visit with the physician. Questionnaires completion will be done by patients on tablets and/or computer terminals via the CHES software (Computer-based Health Evaluation System) at hospital before consultation or at home via secured portal. Physician will immediately have access to a visual summary of HRQOL evaluation.
- Conditions
- Renal Carcinoma Metastatic, Kidney Neoplasms, Renal Cancer
- Being tested
- Electronic PRO in daily clinical practice
- Keywords
- Health Related Quality of Life, Routine clinical practice, Electronic Patient Reported Outcome, EORTC QLQ-C30, Pazopanib, Sunitinib, Tyrosine Kinase Inhibitor anti-VEGF, Patient Reported Outcome, Supportive Care, Quality of Life
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic PRO in daily clinical practiceOther
All patients diagnosed with mRCC initiating TKI anti-VEGF treatment (Sunitinib or Pazopanib) will be invited to complete the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 cancer specific questionnaire and the EQ-5D before each visit with the physician. Questionnaires completion will be done by patients on tablets and/or computer terminals via the CHES software (Computer-based Health Evaluation System) at hospital before consultation or at home via secured portal. Physician will immediately have access to a visual summary of HRQOL evaluation.
| Study group | Role | What they receive |
|---|---|---|
| Electronic PRO | Other | All patients diagnosed with mRCC initiating TKI anti-VEGF treatment (Sunitinib or Pazopanib) will be invited to complete the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 cancer specific questionnaire and the EQ-5D before each visit with the physician. Questionnaires completion will be done by patients on tablets and/or computer terminals via the CHES software (Computer-based Health Evaluation System) at hospital before consultation or at home via secured portal. Physician will immediately have access to a visual summary of HRQOL evaluation. Receives: Other: Electronic PRO in daily clinical practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of filled questionnaires at 12-months
Number of completed questionnaires compared to the number of consultations carried out during the first 12 months of follow-up.
Measured: 12 months
Secondary outcomes (4)
Exhaustiveness
Number of new cases for each center, initiating a treatment per ITK molecule compared to the number of patients to whom the intervention was proposed
Measured: 24 months
Acceptability
Number of patients who agreed to participate in this study compared to the number of refusals on all patients, by center and by molecule type (Sunitinib or Pazopanib)
Measured: 24 months
Effectiveness
Description of the toxicities collected by physicians according to the NCI CTCAE V4 compared to the toxicities reported by patients according to the 8 symptomatic dimensions of the QLC-C30 questionnaire and 9 items from EORTC Item Bank exploring 6 supplementary symptomatic dimensions
Measured: 24 months
Physician satisfaction
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start4 May 2017
- Primary completion4 Nov 2019 (estimated)
- Study completion4 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal Carcinoma MetastaticStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume MOUILLET, MD, Principal investigator, Centre Hospitalier Universitairede Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03062410
- Sponsor's protocol ID
- R/2016/54
- Acronym
- QUANARIE
- Status last verified
- Jul 2018
- First submitted
- 20 Feb 2017
- Last updated
- 26 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mouillet G, Fritzsch J, Paget-Bailly S, Pozet A, Es-Saad I, Meurisse A, Vernerey D, Mouyabi K, Berthod D, Bonnetain F, Anota A, Thiery-Vuillemin A. 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. Health Qual Life Outcomes. 2019 Feb 4;17(1):25. doi: 10.1186/s12955-019-1085-1.
PubMed 30717745
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT03062410
- Acronym / sponsor ID
- QUANARIE / R/2016/54
- Conditions
- Renal Carcinoma Metastatic, Kidney Neoplasms, Renal Cancer
- Keywords
- Health Related Quality of Life, Routine clinical practice, Electronic Patient Reported Outcome, EORTC QLQ-C30, Pazopanib, Sunitinib, Tyrosine Kinase Inhibitor anti-VEGF, Patient Reported Outcome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 4 May 2017 (actual)
- Primary completion
- 4 Nov 2019 (estimated)
- Study completion
- 4 Feb 2020 (estimated)
- First posted
- 23 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
QUANARIE study is an interventional, prospective, multicenter trial involving 9 french oncological centers. Patients diagnosed with mRCC initiating TKI anti-VEGF treatment (Sunitinib or Pazopanib) will be invited to complete the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 cancer specific questionnaire and the EQ-5D before each visit with the physician. Questionnaires completion will be done by patients on tablets and/or computer terminals via the CHES software (Computer-based Health Evaluation System) at hospital before consultation or at home via secured portal. Physician will immediately have access to a visual summary of HRQOL evaluation.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Electronic PRO | Other | Other: Electronic PRO in daily clinical practiceAll patients diagnosed with mRCC initiating TKI anti-VEGF treatment (Sunitinib or Pazopanib) will be invited to complete the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 cancer specific questionnaire and the EQ-5D before each visit with the physician. Questionnaires completion will be done by patients on tablets and/or computer terminals via the CHES software (Computer-based Health Evaluation System) at hospital before consultation or at home via secured portal. Physician will immediately have access to a visual summary of HRQOL evaluation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electronic PRO in daily clinical practiceAll patients diagnosed with mRCC initiating TKI anti-VEGF treatment (Sunitinib or Pazopanib) will be invited to complete the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 cancer specific questionnaire and the EQ-5D before each visit with the physician. Questionnaires completion will be done by patients on tablets and/or computer terminals via the CHES software (Computer-based Health Evaluation System) at hospital before consultation or at home via secured portal. Physician will immediately have access to a visual summary of HRQOL evaluation. | Other | Electronic PRO |
Primary outcome
Rate of filled questionnaires at 12-months
Time frame: 12 months
Number of completed questionnaires compared to the number of consultations carried out during the first 12 months of follow-up.
4 secondary outcomes
Exhaustiveness
Time frame: 24 months
Acceptability
Time frame: 24 months
Effectiveness
Time frame: 24 months
Physician satisfaction
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
- Derived from this study: PubMed 30717745Mouillet G, Fritzsch J, Paget-Bailly S, Pozet A, Es-Saad I, Meurisse A, Vernerey D, Mouyabi K, Berthod D, Bonnetain F, Anota A, Thiery-Vuillemin A. 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. Health Qual Life Outcomes. 2019 Feb 4;17(1):25. doi: 10.1186/s12955-019-1085-1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillaume MOUILLET, MD principal investigator
Centre Hospitalier Universitairede Besançon
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic PRO in daily clinical practice in people with Renal Carcinoma Metastatic and Kidney Neoplasms, run by Centre Hospitalier Universitaire de Besancon at 8 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guillaume MOUILLET, MD (0033370632266, gmouillet@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of filled questionnaires at 12-months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03062410, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2018.