Patient Starting BevacizumabSAVENCT03842917
SAlt Diet and Various Biomarkers Effects on Blood Pressure and Proteinuria During Inhibition of VEGF)
An observational study of Patient Starting Bevacizumab and Cancer, run by University Hospital, Tours at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Starting Bevacizumab, Cancer
- What is being tested?
- Biological samples and Blood pressure measurement
- How many people
- 26 participants
- Where
- 3 sitesFrance
- Study dates
- 26 Apr 2019to 15 Jun 2022
- Phase
- Observational
- 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
Study population: Patients with solid cancers who will be starting treatment with bevacizumab as part of the standard treatment
Who may be able to join
- Adult patient
- With a solid cancer for which a treatment with bevacizumab (Avastin®) is indicated in accordance with its marketing authorization
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites
Medical Oncology Service, University Hospital, Tours
Tours, 37044
Oncological Gastroenterology Service, University Hospital, Tours
Tours, 37044
Pneumology, University Hospital, Tours
Tours, 37044
About this study
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
- Conditions
- Patient Starting Bevacizumab, Cancer
- Being tested
- Biological samples, Blood pressure measurement
- Keywords
- Cancer, bevacizumab, blood pressure, proteinuria
- Medical subject headings
- Neoplasms, Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological samplesOther
Urine and blood samples
Blood pressure measurementOther
Home blood pressure self-measurement and hospital blood pressure measurement
| Study group | Role | What they receive |
|---|---|---|
| Patient starting bevacizumab treatment for cancer | Taken biological samples (urine and blood) and blood pressure measurement on patients starting bevacizumab treatment for cancer Receives: Other: Biological samples; Other: Blood pressure measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: before the initiation of bevacizumab and before each bevacizumab infusion, up to 10 weeks
Secondary outcomes (2)
in-hospital blood pressure measurement
Standardized measurement of in-hospital blood pressure (systolic, diastolic) and heart rate during bevacizumab infusion
Measured: before the initiation of bevacizumab and before each bevacizumab infusion, up to 10 weeks
24-hour proteinuria
Measurement of 24 hours proteinuria
Measured: before the initiation of bevacizumab and before each bevacizumab infusion, up to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start26 Apr 2019
- Primary completion27 Apr 2022
- Study completion15 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient Starting BevacizumabStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Theodora BEJAN-ANGOULVANT, MD-PhD, Study director, University Hospital, Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03842917
- Sponsor's protocol ID
- RIPH3-RNI18/SAVE
- Other IDs
- 2018-A03137-48
- Acronym
- SAVE
- Status last verified
- Nov 2022
- First submitted
- 8 Feb 2019
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SAlt Diet and Various Biomarkers Effects on Blood Pressure and Proteinuria During Inhibition of VEGF)
- ClinicalTrials.gov ID
- NCT03842917
- Acronym / sponsor ID
- SAVE / RIPH3-RNI18/SAVE
- Conditions
- Patient Starting Bevacizumab, Cancer
- Keywords
- Cancer, bevacizumab, blood pressure, proteinuria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 26 Apr 2019 (actual)
- Primary completion
- 27 Apr 2022 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 15 Feb 2019 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient starting bevacizumab treatment for cancer | – | Other: Biological samples, Other: Blood pressure measurementTaken biological samples (urine and blood) and blood pressure measurement on patients starting bevacizumab treatment for cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with solid cancers who will be starting treatment with bevacizumab as part of the standard treatment
Key inclusion criteria (2 listed)
- Adult patient
- With a solid cancer for which a treatment with bevacizumab (Avastin®) is indicated in accordance with its marketing authorization
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Biological samplesUrine and blood samples | Other | Patient starting bevacizumab treatment for cancer |
| Blood pressure measurementHome blood pressure self-measurement and hospital blood pressure measurement | Other | Patient starting bevacizumab treatment for cancer |
Primary outcome
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
2 secondary outcomes
in-hospital blood pressure measurement
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
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.
Theodora BEJAN-ANGOULVANT, MD-PhD study director
University Hospital, Tours
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Starting Bevacizumab and Cancer, run by University Hospital, Tours at 3 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Home blood pressure measurement (time frame: before the initiation of bevacizumab and before each bevacizumab infusion, up to 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Nov 2022.