Vascular Dysfunction and Antiangiogenic Therapy

NCT02161978 | Completed DMC

• 1 other identifier: 2011-A00441-40
• Study Type: observational
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

antiangiogenic; cancer; vascular; biomarker; tyrosine kinase inhibitor

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

University Hospital Angers

Angers, 49933, France

Location

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Neoplasms

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Samir HENNI, MD

  University hospital, Angers, FRANCE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2014
• First Posted: June 12, 2014
• Study Start: February 9, 2012
• Primary Completion: December 12, 2018
• Study Completion: December 12, 2018
• Last Updated: November 6, 2019

Record last verified: 2019-11

Locations

FR (1)