Vascular Dysfunction and Antiangiogenic Therapy (DYVA-AAGG)

November 5, 2019 updated by: University Hospital, Angers

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

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

93

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49933
        • University Hospital Angers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Investigators

  • Principal Investigator: Samir HENNI, MD, University hospital, Angers, FRANCE

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 9, 2012

Primary Completion (Actual)

December 12, 2018

Study Completion (Actual)

December 12, 2018

Study Registration Dates

First Submitted

June 2, 2014

First Submitted That Met QC Criteria

June 10, 2014

First Posted (Estimate)

June 12, 2014

Study Record Updates

Last Update Posted (Actual)

November 6, 2019

Last Update Submitted That Met QC Criteria

November 5, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-A00441-40

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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