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Vascular Dysfunction and Antiangiogenic Therapy (DYVA-AAGG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02161978
Recruitment Status : Completed
First Posted : June 12, 2014
Last Update Posted : November 6, 2019
Information provided by (Responsible Party):
University Hospital, Angers

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

Condition or disease
Solid Tumor Tumor Angiogenesis Endothelial Dysfunction CML (Chronic Myelogenous Leukemia)

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).

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Study Type : Observational
Actual Enrollment : 93 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Micro and Macro Vascular Dysfunction Induced by Antiangiogenic Therapy: Identification of New Vascular Biomarkers (DYVA-AAGG)
Actual Study Start Date : February 9, 2012
Actual Primary Completion Date : December 12, 2018
Actual Study Completion Date : December 12, 2018

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02161978

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University Hospital Angers
Angers, France, 49933
Sponsors and Collaborators
University Hospital, Angers
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Principal Investigator: Samir HENNI, MD University hospital, Angers, FRANCE
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Responsible Party: University Hospital, Angers Identifier: NCT02161978    
Other Study ID Numbers: 2011-A00441-40
First Posted: June 12, 2014    Key Record Dates
Last Update Posted: November 6, 2019
Last Verified: November 2019
Keywords provided by University Hospital, Angers:
tyrosine kinase inhibitor
Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases