- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00428688
Endothelial Function and IMT in Survivors of Hodgkin's Lymphoma
Assessment of Endothelial Function and IMT in Survivors Hodgkin's Lymphoma Patients
Study Overview
Status
Conditions
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Ramat-Gan, Israel, 52621
- The Endothelaial function lab, The Heart Institute, Sheba Medical Center, Israel
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Hodgkin's disease survivors over 18 years old
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Frequencey of endothelial dysfunction by FMD
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dalit Modan, M.D, Sheba Medical Center
- Principal Investigator: Michael Schechter, M.D, Sheba Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SHEBA-06-4359-DM-CTIL
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.
Clinical Trials on Hodgkin's Lymphoma
-
University Health Network, TorontoCompletedHodgkin's Lymphoma | Non Hodgkin's LymphomaCanada
-
PrECOG, LLC.Genentech, Inc.CompletedFollicular Lymphoma | Non-Hodgkin's Lymphoma Follicular | Non-Hodgkin's Lymphoma, Adult High GradeUnited States
-
Memorial Sloan Kettering Cancer CenterRecruitingNon-Hodgkin Lymphoma | Non-Hodgkin's Lymphoma, Relapsed | Non-Hodgkin's Lymphoma RefractoryUnited States
-
Immune DesignMerck Sharp & Dohme LLCTerminatedFollicular Low Grade Non-Hodgkin's Lymphoma
-
Haihe Biopharma Co., Ltd.RecruitingAdvanced Solid Tumor | Non-Hodgkin's Lymphoma, Relapsed | Non-Hodgkin's Lymphoma RefractoryUnited States, China
-
Tarapeutics Science Inc.RecruitingAdvanced Solid Tumor | Non-Hodgkin's Lymphoma, Relapsed | Non-Hodgkin's Lymphoma RefractoryChina
-
Hoffmann-La RocheCompletedDiffuse Large B-Cell Lymphoma, Non-Hodgkin's LymphomaHong Kong, Germany, Philippines, Taiwan, Turkey, Canada, Australia, Austria, New Zealand, Thailand, Hungary, Italy, Korea, Republic of, Romania, Netherlands, Brazil, Indonesia, Croatia, Egypt, Portugal, Sweden, Colombia, Argentina, De... and more
-
Auxilio Mutuo Cancer CenterCompletedRefractory Aggressive Non-Hodgkin's Lymphoma | Relapsing Aggressive Non-Hodgkin's Lymphoma
-
Western Regional Medical CenterWithdrawnLymphoma | Hodgkin's Lymphoma | Non-hodgkin's LymphomaUnited States
-
West Virginia UniversityCompletedHodgkin's Lymphoma | Non-Hodgkin's LymphomaUnited States