Vascular Dysfunction and Antiangiogenic Therapy

Micro and Macro Vascular Dysfunction Induced by Antiangiogenic Therapy: Identification of New Vascular Biomarkers (DYVA-AAGG)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02161978

Acronym

DYVA-AAGG

Enrollment

Registered

2014-06-12

Start date

2012-02-09

Completion date

2018-12-12

Last updated

2019-11-06

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

Conditions

CML (Chronic Myelogenous Leukemia), Endothelial Dysfunction, Solid Tumor, Tumor Angiogenesis

Keywords

antiangiogenic, cancer, vascular, biomarker, tyrosine kinase inhibitor

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).

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

France

Outcome results