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CompletedNCT03842917SAVEUpdated Nov 8, 2022

SAlt Diet and Various Biomarkers Effects on Blood Pressure and Proteinuria During Inhibition of VEGF)

An observational study in Patient Starting Bevacizumab and Cancer, sponsored by University Hospital, Tours. Completed at 3 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-08.

Sponsored by University Hospital, Tours · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
26
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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
02

Conditions studied

  • Patient Starting Bevacizumab
  • Cancer

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Keywords

  • Cancer
  • bevacizumab
  • blood pressure
  • proteinuria
03

In context

Proteinuria

234 studies on the registry are indexed under Proteinuria; 43 are open to participants now.

This study's enrollment of 26 is below the median of 125 across 53 observational studies indexed under Proteinuria.

Browse Proteinuria studies →

Lead sponsor

University Hospital, Tours is the lead sponsor of 304 studies on the registry; 78 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with solid cancers who will be starting treatment with bevacizumab as part of the standard treatment

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
26 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Patient starting bevacizumab treatment for cancer

    Taken biological samples (urine and blood) and blood pressure measurement on patients starting bevacizumab treatment for cancer

    Other: Biological samples · Other: Blood pressure measurement

Interventions

  • OtherBiological samples

    Urine and blood samples

  • OtherBlood pressure measurement

    Home blood pressure self-measurement and hospital blood pressure measurement

06

What researchers measure

Primary outcomes

  1. Home blood pressure measurement

    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

    Time frame: before the initiation of bevacizumab and before each bevacizumab infusion, up to 10 weeks

Secondary outcomes

  1. in-hospital blood pressure measurement

    Standardized measurement of in-hospital blood pressure (systolic, diastolic) and heart rate during bevacizumab infusion

    Time frame: before the initiation of bevacizumab and before each bevacizumab infusion, up to 10 weeks

  2. 24-hour proteinuria

    Measurement of 24 hours proteinuria

    Time frame: before the initiation of bevacizumab and before each bevacizumab infusion, up to 10 weeks

07

Study locations

3 sites
  • Medical Oncology Service, University Hospital, Tours
    Tours, 37044, France
  • Oncological Gastroenterology Service, University Hospital, Tours
    Tours, 37044, France
  • Pneumology, University Hospital, Tours
    Tours, 37044, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03842917
Lead sponsor
University Hospital, Tours
Responsible party
Sponsor
First posted
Feb 15, 2019
Start date
Apr 26, 2019
Primary completion
Apr 27, 2022
Completion
Jun 15, 2022
Last update
Nov 8, 2022

Study contacts

Theodora BEJAN-ANGOULVANT, MD-PhD
study director · University Hospital, Tours

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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