Clinical trial NCT02161978: Vascular Dysfunction and Antiangiogenic Therapy
Official title: Micro and Macro Vascular Dysfunction Induced by Antiangiogenic Therapy: Identification of New Vascular Biomarkers (DYVA-AAGG)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Solid Tumor
Tumor Angiogenesis
Endothelial Dysfunction
CML (Chronic Myelogenous Leukemia)
Keywords: antiangiogenic
cancer
vascular
biomarker
tyrosine kinase inhibitor
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2014-06-12
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated for a solid tumor (kidney, pancreas, intestinal, breast, lungs, skin) requiring a first or second line antiangiogenic therapy and Hemopathy

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).

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)

Primary outcomes:
measure: Changes induced by antiangiogenic drugs and tyrosine kinase inhibitor in the vascular ultrasound variables
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: University Hospital Angers
Study officials:
affiliation: University hospital, Angers, FRANCE
name: Samir HENNI, MD
role: PRINCIPAL_INVESTIGATOR
References: