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

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ClinicalTrials.gov Identifier: NCT03842917
Recruitment Status : Recruiting
First Posted : February 15, 2019
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Tours

Brief 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.


Condition or disease Intervention/treatment
Patient Starting Bevacizumab Cancer Other: Biological samples Other: Blood pressure measurement

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

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: SAlt Diet and Various Biomarkers Effects on Blood Pressure and Proteinuria During Inhibition of VEGF)
Actual Study Start Date : April 26, 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

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
Other: Biological samples
Urine and blood samples

Other: Blood pressure measurement
Home blood pressure self-measurement and hospital blood pressure measurement




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 24-hour proteinuria [ Time Frame: before the initiation of bevacizumab and before each bevacizumab infusion, up to 10 weeks ]
    Measurement of 24 hours proteinuria


Biospecimen Retention:   Samples Without DNA
urine and blood samples will be drawn to measure proteinuria and concentration of various biomarkers (as listed above)


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03842917


Contacts
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Contact: Théodora BEJAN-ANGOULVANT, MD-PhD 02 34 37 96 65 ext +33 theodora.angoulvant@univ-tours.fr
Contact: Amelie LEGRAND A.LEGRAND@chu-tours.fr

Locations
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France
Medical Oncology Service, University Hospital, Tours Recruiting
Tours, France, 37044
Contact: Hélène VEGAS, MD         
Principal Investigator: Hélène VEGAS, MD         
Oncological Gastroenterology Service, University Hospital, Tours Recruiting
Tours, France, 37044
Contact: Morgane CAULET, MD         
Principal Investigator: Morgane CAULET, MD         
Sponsors and Collaborators
University Hospital, Tours
Investigators
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Study Director: Theodora BEJAN-ANGOULVANT, MD-PhD University Hospital, Tours

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Responsible Party: University Hospital, Tours
ClinicalTrials.gov Identifier: NCT03842917     History of Changes
Other Study ID Numbers: RIPH3-RNI18/SAVE
2018-A03137-48 ( Other Identifier: IdRCB )
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Tours:
Cancer
bevacizumab
blood pressure
proteinuria
Additional relevant MeSH terms:
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Proteinuria
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors