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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-A03137-48 | Other Identifier | IdRCB |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient starting bevacizumab treatment for cancer | Taken biological samples (urine and blood) and blood pressure measurement on patients starting bevacizumab treatment for cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biological samples | Other | Urine and blood samples |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | before the initiation of bevacizumab and before each bevacizumab infusion, up to 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| in-hospital blood pressure measurement | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with solid cancers who will be starting treatment with bevacizumab as part of the standard treatment
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| Name | Affiliation | Role |
|---|---|---|
| Theodora BEJAN-ANGOULVANT, MD-PhD | University Hospital, Tours | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Oncology Service, University Hospital, Tours | Tours | 37044 | France | |||
| Oncological Gastroenterology Service, University Hospital, Tours |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D011507 | Proteinuria |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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urine and blood samples will be drawn to measure proteinuria and concentration of various biomarkers (as listed above)
| Blood pressure measurement |
| Other |
Home blood pressure self-measurement and hospital blood pressure measurement |
|
Measurement of 24 hours proteinuria |
| before the initiation of bevacizumab and before each bevacizumab infusion, up to 10 weeks |
| Tours |
| 37044 |
| France |
| Pneumology, University Hospital, Tours | Tours | 37044 | France |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |