Mabtornib protocol. Vascular, metabolic and hormonal effects of angiogenesis inhibitors and EGFR inhibitors.

Mabtornib protocol. Vascular, metabolic and hormonal effects of angiogenesis inhibitors and EGFR inhibitors. - Side effects of VEGF and EGFR directed therapy.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON33675

Enrollment

240

Registered

2008-11-20

Start date

2008-03-25

Completion date

Unknown

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Side effects

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Patients treated with angiogenesis or EGFR inhibitors. Concomitant chemotherapy, immunotherapy or radiotherapy is allowed. - Age above 18 years at start of treatment - Willingness to give written informed consent

Exclusion criteria

Exclusion criteria: -Unable to give written informed consent - Age under 18 years

Design outcomes

Primary

Measure	Time frame
Patients will be evaluated for vascular changes by measuring 24-hour ambulatory blood pressure, baroreflex sensitivity, nail fold capillary microscopy and arterial compliance measurement at 3 time points: before start of treatment, and after 3 and after 6 weeks of treatment. Patients will also be asked to measure their blood pressure at home twice a day, for 6 weeks. Metabolic and hormonal changes and investigation of biomarkers will be done by blood and urine analyses every 3 weeks for the first 3 months, every 6 weeks up to 6 months and every 3 months thereafter, and by skin autofluorescence before treatment and after 3 and after 6 weeks of treatment. Changes in vascular, hormonal and metabolic status will be related to clinical side effects and to response to treatment.	—

Measure

Time frame

Patients will be evaluated for vascular changes by measuring 24-hour ambulatory blood pressure, baroreflex sensitivity, nail fold capillary microscopy and arterial compliance measurement at 3 time points: before start of treatment, and after 3 and after 6 weeks of treatment. Patients will also be asked to measure their blood pressure at home twice a day, for 6 weeks. Metabolic and hormonal changes and investigation of biomarkers will be done by blood and urine analyses every 3 weeks for the first 3 months, every 6 weeks up to 6 months and every 3 months thereafter, and by skin autofluorescence before treatment and after 3 and after 6 weeks of treatment. Changes in vascular, hormonal and metabolic status will be related to clinical side effects and to response to treatment.

—

Secondary

Measure	Time frame
When clinically relevant differences in side effects and response to treatment are found among patients treated with the same agent, DNA analysis will be carried out to investigate if changes in candidate genes are related to these differences.	—

Countries

Netherlands

Outcome results