- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03842917
SAlt Diet and Various Biomarkers Effects on Blood Pressure and Proteinuria During Inhibition of VEGF) (SAVE)
Bevacizumab is an anti-angiogenic treatment used to treat various solid cancers. Previous studies have shown that this treatment may have adverse effects like hypertension and proteinuria.
This is an exploratory study aiming to better understand the relationship between various biomarkers and blood pressure changes and proteinuria measured for 4 to 6 weeks after the first infusion of anti-VEGF therapy with bevacizumab.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Participants will be invited to participate to this research study by their oncologist within 1 to 2 weeks before starting bevacizumab treatment, as part of standard treatment. They will finish the research at the end of the third infusion of bevacizumab.
Patients will perform a home blood pressure self-measurement over three days and will collect urine over 24 hours prior to the start of each bevacizumab infusion at cycles 1, 2 and 3. Blood pressure measurements will also be performed during each bevacizumab infusion and blood tests will be performed before each infusion to measure the following biomarkers:
- Salt consumption as estimated by 24-hour natriuresis measured before each of the first 3 infusions
- 24 hours aldosterone excretion measured before the first and third infusions
- plasma methoxylated derivatives measured before the first and third infusions
- NTproBNP measured before the first and third infusions
- 24 hours urinary free cortisol measured before the first and third infusions
- bevacizumab trough concentration measured before the first three bevacizumab infusion
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Tours, France, 37044
- Medical Oncology Service, University Hospital, Tours
-
Tours, France, 37044
- Oncological Gastroenterology Service, University Hospital, Tours
-
Tours, France, 37044
- Pneumology, University Hospital, Tours
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult patient
- With a solid cancer for which a treatment with bevacizumab (Avastin®) is indicated in accordance with its marketing authorization
Exclusion Criteria:
- Renal cancer
- Recent changes in antihypertensive treatment(s) in the last month, with the exception for diuretics where treatment stability of at least 3 months will be required
- Patients who do not wish to participate to the study
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patient starting bevacizumab treatment for cancer
Taken biological samples (urine and blood) and blood pressure measurement on patients starting bevacizumab treatment for cancer
|
Urine and blood samples
Home blood pressure self-measurement and hospital blood pressure measurement
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Home blood pressure measurement
Time Frame: before the initiation of bevacizumab and before each bevacizumab infusion, up to 10 weeks
|
Home blood pressure (systolic, diastolic) before each bevacizumab infusion, as the mean of 3 measures in the morning and 3 measures in the evening, over 3 days
|
before the initiation of bevacizumab and before each bevacizumab infusion, up to 10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
in-hospital blood pressure measurement
Time Frame: before the initiation of bevacizumab and before each bevacizumab infusion, up to 10 weeks
|
Standardized measurement of in-hospital blood pressure (systolic, diastolic) and heart rate during bevacizumab infusion
|
before the initiation of bevacizumab and before each bevacizumab infusion, up to 10 weeks
|
24-hour proteinuria
Time Frame: before the initiation of bevacizumab and before each bevacizumab infusion, up to 10 weeks
|
Measurement of 24 hours proteinuria
|
before the initiation of bevacizumab and before each bevacizumab infusion, up to 10 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Theodora BEJAN-ANGOULVANT, MD-PhD, University Hospital, Tours
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RIPH3-RNI18/SAVE
- 2018-A03137-48 (Other Identifier: IdRCB)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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