Radiation Induced Atherosclerosis in Breast Cancer Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2005 by Hadassah Medical Organization.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00388713
First received: October 15, 2006
Last updated: May 15, 2007
Last verified: December 2005
  Purpose

Radiation induced accelerated atherosclerosis is a well known entity that occurs in different regions, according to the therapy delivered.It is usually begins to be clinically evident several years after the radiation incident, as there is sufficient functional reserve to these vessels.Our proposal is aimed to better characterize this side effect. For that purpose, we have chosen to study women who received radiation to the breast, in which part of the carotid in the irradiated side was in the high energy radiation field. We will use Intima Media Thickening ultrasound to study the pattern of atherosclerosis plaque formation in radiated carotid arteries as compared to non-irradiated carotid arteries in women who are receiving radiation therapy for breast cancer.


Condition Intervention
Abnormalities, Radiation-Induced
Atherosclerosis
Breast Cancer
Procedure: carotid intima-media thickening ultrasound

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
Official Title: Radiation Induced Atherosclerosis in Breast Cancer Patients

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Estimated Enrollment: 350
Study Start Date: October 2006
Estimated Study Completion Date: January 2010
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • women 18-85 Y.O.
  • received or about to receive unilateral breast and supraclavicular radiation therapy
  • No evidence of disease

Exclusion Criteria:

  • prisoners
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00388713

Contacts
Contact: Arik Tzukert, DMD 00 972 2 6776095 arik@hadassah.org.il
Contact: Hadas Lemberg, PhD 00 972 2 6777572 lhadas@hadassah.org.il

Locations
Israel
Hadassah Medical Organization Recruiting
Jerusalem, Israel, 91120
Contact: Arik Tzukert, DMD    00 972 2 6776095    arik@hadassah.org.il   
Contact: Hadas Lemberg, PhD    00 972 2 6777572    lhadas@hadassah.org.il   
Principal Investigator: Amichay Meirovitz, MD         
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Amichay Meirovitz, MD Hadassah University Hospital, Jerusalem, Israel
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00388713     History of Changes
Other Study ID Numbers: ASBCO5- HMO-CTIL
Study First Received: October 15, 2006
Last Updated: May 15, 2007
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:
Radiation therapy
Radiation-Induced Atherosclerosis
Carotid Artery Diseases
Breast Cancer
Intima Media thickening Ultrasound

Additional relevant MeSH terms:
Abnormalities, Radiation-Induced
Radiation Injuries
Congenital Abnormalities
Atherosclerosis
Breast Neoplasms
Wounds and Injuries
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 24, 2014