Micro and Macro Vascular Dysfunction Induced by Antiangiogenic Therapy: Identification of New Vascular Biomarkers (DYVA-AAGG)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Solid Tumor
- Sponsor
- University Hospital, Angers
- Enrollment
- 93
- Locations
- 1
- Primary Endpoint
- Changes induced by antiangiogenic drugs and tyrosine kinase inhibitor in the vascular ultrasound variables
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
project is a pilot prospective, longitudinal, before-after, open label multicentric study.
Detailed Description
Antiangiogenic drugs and tyrosine kinase inhibitor (TKI) represent a new therapeutic issue in the treatment of several neoplasic tumors (colon, kidney, breast, lung, skin) and hemopathy. Antiangiogenic drugs acts through neutralization of the activity (e.g. bevacizumab) or the inhibition of post-receptor tyrosine kinase pathways (e.g. sunatinib, sorafenib), leading to a reduction and inhibition of the tumoral tissular neovascularization. Due to the ubiquitous role of and the systemic administration of the antiangiogenic drugs, almost all of them are responsible for several side effects, many involving the cardiovascular system (e.g. arterial hypertension, cardiomyopathies, proteinuria, bleedings,...) and leading to a reduction of the doses or withdrawal of the treatment. To date, the mechanism and the impact of these cardiovascular effects is not well understood involving structural (i.e. capillary rarefaction) and functional vascular dysfunction (i.e. vasomotor dysfunction, stiffening).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Men and women \> 18 years old treated for a solid tumor (kidney, pancreas, breast, lungs, skin) with line antiangiogneic therapy and hemopathy
- •Antiangiogneic therapy can be: bevacizumab, anti- (e.g. sunitinib, sorafenib), proteinate kinases inhibitor (e.g.temsirolimus ) or everolimus or any new allowed therapy with expected antiangiogenic properties and tyrosine kinase inhibitor.
- •Expected life span \> 6 months
- •Clinical state allowing investigations
- •A blood glucose and lipid tests within the last 3 months
Exclusion Criteria
- •Informed consent not obtained
- •Patients presenting a clinical state which does not allow for the performance of the vascular investigations (agitation, cutaneous wound, major asthenia, acute dyspnoea, cadiac arhythmia)
- •Pregnant women
- •Patients \> 18 yrs old protected by the french law
- •Patients without national health insurance
- •Patients included in another biomedical study (this criteria is relative to the other studies)
Outcomes
Primary Outcomes
Changes induced by antiangiogenic drugs and tyrosine kinase inhibitor in the vascular ultrasound variables
Time Frame: 24 months
arterial stiffness, diameter and resistance will be performed using echotracking technologies.