Vascular Dysfunction and Antiangiogenic Therapy

Solid Tumor Clinical Trial

— DYVA-AAGG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02161978
• Other study ID #: 2011-A00441-40
• Status: Completed
• Start date: February 9, 2012
• Est. completion date: December 12, 2018

Study information

• Verified date: November 2019
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

project is a pilot prospective, longitudinal, before-after, open label multicentric study.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: December 12, 2018
• Est. primary completion date: December 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• CML (Chronic Myelogenous Leukemia)
• Endothelial Dysfunction
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Solid Tumor
• Tumor Angiogenesis

Locations

Country	Name	City	State
France	University Hospital Angers	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes induced by antiangiogenic drugs and tyrosine kinase inhibitor in the vascular ultrasound variables	arterial stiffness, diameter and resistance will be performed using echotracking technologies.	24 months