We hypothesize that podocyturia is an early marker of ongoing renal damage during angiogenesis inhibition.
ID
Bron
Aandoening
Podocyturia as a possible early marker of renal toxicity during angiogenesis inhibition
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Incidence of podocyturia during treatment with an angiogenesis inhibitor
Doel van het onderzoek
We hypothesize that podocyturia is an early marker of ongoing renal damage during angiogenesis inhibition.
Onderzoeksopzet
Cross-sectionally during treatment with an angiogenesis inhibitor or chemotherapy a spot urine sample will be collected once.
Onderzoeksproduct en/of interventie
Sixty patients treated with an anti-VEGF monoclonal antibody or RTKI at the department of Oncology of the Amphia hospital will be invited to participate in our study. During a routine visit at the outpatient clinic a morning spot urine sample will be collected cross-sectionally during treatment to measure podocyturia. Also blood pressure will be measured. Furthermore, patients characteristics will be collected. Since treatment with an angiogenesis inhibitor is often combined with chemotherapy, in a comparable group of 20 patients treated with this chemotherapy without an angiogenesis inhibitor, urine samples will be collected to assess podocyturia (= control group 1). Likewise, podocyturia will be determined in 10 'healthy' (control) subjects who visit the outpatient clinic for other medical issues (e.g. analysis of fatigue, abdominal pain, etc. [ = control group 2]).
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Patients with malignancy treated with an anti-VEGF monoclonal antibody or receptor tyrosine kinase inhibitor (RTKI) + chemotherapy
- Patients treated with chemotherapy alone (without an anti-VEGF monoclonal antibody or RTKI) = control group 1
- 'Healthy' patients without malignancy and normal kidney function (MDRD > 60 ml/min) without proteinuria (see also exclusion criteria) = control group 2
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Healthy controls (control group 2) with abnormal kidney function and/or proteinuria (protein-to-creatinine ratio > 45 mg/mmol or albumin-to-creatinine ratio > 30 mg/mmol)
- Known renal insufficiency (MDRD < 60 ml/min) in patients with malignancy and/or proteinuria (protein-to-creatinine ratio > 45 mg/mmol or albumin-to-creatinine ratio > 30 mg/mmol) if this latter has been previously reported
- Previous therapy with an anti-VEGF monoclonal antibody or RTKI
- Concomitant chemotherapy frequently associated with renal injury (>10% of patients), e.g. cisplatinum
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5112 |
| NTR-old | NTR5244 |
| Ander register | METC has approved the project, but did not assign an ID : MHWK01 |