Vascular Dysfunction and Antiangiogenic Therapy

Completed

• Conditions: Endothelial Dysfunction; Solid Tumor; CML (Chronic Myelogenous Leukemia); Tumor Angiogenesis

• Registration Number: NCT02161978
• Lead Sponsor: University Hospital, Angers

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).

Study Timeline

• Study Start: 2012-02-09
• Study First Submitted: 2014-06-02
• Study First Submitted QC: 2014-06-10
• Study First Posted: 2014-06-12
• Primary Completion: 2018-12-12
• Study Completion: 2018-12-12
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-05
• Last Update Posted: 2019-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes induced by antiangiogenic drugs and tyrosine kinase inhibitor in the vascular ultrasound variables	24 months	arterial stiffness, diameter and resistance will be performed using echotracking technologies.

Trial Locations

Locations (1)

University Hospital Angers; 🇫🇷 Angers, France