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Endothelial Function and IMT in Survivors of Hodgkin's Lymphoma

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: NCT00428688
Recruitment Status : Unknown
Verified December 2012 by Dr. Dalit Modan, Sheba Medical Center.
Recruitment status was:  Enrolling by invitation
First Posted : January 30, 2007
Last Update Posted : December 13, 2012
Information provided by (Responsible Party):
Dr. Dalit Modan, Sheba Medical Center

Brief Summary:
The aim of the proposed study is to assess endothelial function and IMT, as correlates of cardiovascular disease (CVD), in young adult Hodgkin's disease (HD) survivors, and to relate endothelial function to other risk factors including obesity, dyslipidemia, hyperinsulinemia and fasting glucose.

Condition or disease
Hodgkin's Lymphoma

Detailed Description:

Disease free survival of Hodgkin's disease (HD) patients has improved dramatically over the past few decades. With the dramatic advance in patient's survival, the prevention and treatment of long-term adverse effects of chemotherapy and radiotherapy has become a major focus of interest. HD survivors have excess mortality compared with the age-matched general population, even after excluding disease relapse. A considerable proportion of the excess mortality is due to cardiovascular disease (CVD), principally ischemic heart disease and stroke.

The proposed study will assess endothelial function in HD survivors, using the non-invasive technique of brachial artery flow-mediated dilation (FMD), by high-resolution ultrasonography. We will also assess IMT. The results of these tests are independent predictors of atherosclerosis disease progression and cardiovascular event rates. This is a prospective study comprising 40 young-adult (aged 18-30 years) . The study will comprise 40 survivors of HD: 20 patients treated with chemotherapy and radiotherapy to the chest and 20 patients treated with chemotherapy alone. The patients will be compared to age and sex-matched patients from the data base of the endothelial function laboratory at the heart institute of the Sheba Medical Center. In addition to brachial artery endothelial function assessment, the patients will also undergo a physical examination including anthropometric measurements (height, weight, waist and hip circumference), and blood pressure. The evaluation will also include blood tests for glucose, lipid profile, CRP, AST, ALT and insulin. A medical history including smoking history and family history of CVD and dyslipidemia will be obtained.

Patients treated with radiotherapy to the chest will be compared to patients treated with chemotherapy alone and both patients will be compared to healthy controls. The patients will be characterized by age, risk factors for coronary heart disease and endothelial function as assessed by brachial artery FMD. We will establish the rate of endothelial function abnormalities in survivors of HD and its correlation with the other risk factors.

Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Assessment of Endothelial Function and IMT in Survivors Hodgkin's Lymphoma Patients
Study Start Date : July 2009
Estimated Primary Completion Date : August 2014
Estimated Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Frequencey of endothelial dysfunction by FMD [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Young-adult survivors of Hodgkin's disease

Inclusion Criteria:

  • Hodgkin's disease survivors over 18 years old

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): NCT00428688

The Endothelaial function lab, The Heart Institute, Sheba Medical Center, Israel
Ramat-Gan, Israel, 52621
Sponsors and Collaborators
Sheba Medical Center
Principal Investigator: Dalit Modan, M.D Sheba Medical Center
Principal Investigator: Michael Schechter, M.D Sheba Medical Center

Responsible Party: Dr. Dalit Modan, Pediatirc Endocrinologist, Sheba Medical Center Identifier: NCT00428688     History of Changes
Other Study ID Numbers: SHEBA-06-4359-DM-CTIL
First Posted: January 30, 2007    Key Record Dates
Last Update Posted: December 13, 2012
Last Verified: December 2012

Keywords provided by Dr. Dalit Modan, Sheba Medical Center:
Hodgkin's lymphoma
cardiovascular disease
radiation therapy
Brachial artery flow-mediated dilation (FMD)

Additional relevant MeSH terms:
Hodgkin Disease
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases