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Radiation Induced Atherosclerosis in Breast Cancer Patients

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.
 
ClinicalTrials.gov Identifier: NCT00388713
Recruitment Status : Unknown
Verified December 2005 by Hadassah Medical Organization.
Recruitment status was:  Recruiting
First Posted : October 17, 2006
Last Update Posted : May 16, 2007
Sponsor:
Information provided by:
Hadassah Medical Organization

Brief Summary:
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 or disease Intervention/treatment
Abnormalities, Radiation-Induced Atherosclerosis Breast Cancer Procedure: carotid intima-media thickening ultrasound

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Study Type : Observational
Estimated Enrollment : 350 participants
Observational Model: Defined Population
Time Perspective: Prospective
Official Title: Radiation Induced Atherosclerosis in Breast Cancer Patients
Study Start Date : October 2006
Estimated Study Completion Date : January 2010

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes 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

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 ClinicalTrials.gov identifier (NCT number): NCT00388713


Contacts
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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
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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
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Principal Investigator: Amichay Meirovitz, MD Hadassah University Hospital, Jerusalem, Israel
Publications:
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ClinicalTrials.gov Identifier: NCT00388713    
Other Study ID Numbers: ASBCO5- HMO-CTIL
First Posted: October 17, 2006    Key Record Dates
Last Update Posted: May 16, 2007
Last Verified: December 2005
Keywords provided by Hadassah Medical Organization:
Radiation therapy
Radiation-Induced Atherosclerosis
Carotid Artery Diseases
Breast Cancer
Intima Media thickening Ultrasound
Additional relevant MeSH terms:
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Breast Neoplasms
Atherosclerosis
Abnormalities, Radiation-Induced
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Congenital Abnormalities
Radiation Injuries
Wounds and Injuries