NCT00428688

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 30, 2007

Completed
2.4 years until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

April 12, 2023

Status Verified

April 1, 2023

Enrollment Period

5.1 years

First QC Date

January 28, 2007

Last Update Submit

April 11, 2023

Conditions

Hodgkin's Lymphoma

Keywords

Hodgkin's lymphomacardiovascular diseaseradiation therapyBrachial artery flow-mediated dilation (FMD)

Outcome Measures

Primary Outcomes (1)

  • Frequencey of endothelial dysfunction by FMD

    2 years

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Young-adult survivors of Hodgkin's disease

You may qualify if:

  • Hodgkin's disease survivors over 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Endothelaial function lab, The Heart Institute, Sheba Medical Center, Israel

Ramat Gan, 52621, Israel

Location

MeSH Terms

Conditions

Hodgkin DiseaseCardiovascular Diseases

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Dalit Modan, M.D

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

  • Michael Schechter, M.D

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pediatirc Endocrinologist

Study Record Dates

First Submitted

January 28, 2007

First Posted

January 30, 2007

Study Start

July 1, 2009

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

April 12, 2023

Record last verified: 2023-04

Locations

IL(1)