NCT00165425

Brief Summary

The main purpose of this study is to determine if it is possible to put into practice a cardiac screening program for survivors of Hodgkin's disease. In this study, we would also like to screen for cardiac risk factors that can be modified either through life-style changes or medications, to uncover significant abnormal heart findings in which treatments may be needed, and to see if there is a link between cardiac health and quality of life.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
31mo left

Started Feb 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
active not recruiting

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

Study Progress90%
Feb 2004Dec 2028

Study Start

First participant enrolled

February 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
21.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Expected
Last Updated

September 10, 2025

Status Verified

September 1, 2025

Enrollment Period

3.7 years

First QC Date

September 9, 2005

Last Update Submit

September 3, 2025

Conditions

Hodgkin's Disease

Keywords

Cardiac screeningCardiac stress testEchocardiogram

Outcome Measures

Primary Outcomes (1)

  • To determine the feasibility of a cardiac screening program in patients who are 5 to 10 years our from initial mediastinal irradiation for Hodgkin's disease.

    Compliance of screening and follow up visits are tracked

    3 years

Secondary Outcomes (3)

  • To prospectively collect data on the prevalence of modifiable cardiac risk factors and the spectrum of cardiac structural abnormalities in this patient populations

    3 years

  • to correlate cardiac structural abnormalities with quality of life

    3 years

  • to correlate cardiac structural abnormalities with level of fatigue.

    3 years

Study Arms (1)

Cardiac screening

EXPERIMENTAL

Interventions: Participants will * meet with study cardiologist * undergo cardiac risk factors screening * undergo resting and stress echocardiogram (echo and stress echo)

Procedure: Echo/Stress Echo

Interventions

Echo/Stress EchoPROCEDURE

Participants will under resting echocardiogram and stress echocardiogram (echo and stress echo) and the results will be interpreted by a cardiologist

Cardiac screening

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients treated at Brigham and Women's Hospital or Dana-Farber Cancer Institute for Hodgkin's disease with mediastinal irradiation
  • Age \> or = to 15 years of age
  • Five years or longer after initial treatment
  • Relapse-free interval of \> 1 year

You may not qualify if:

  • Patients treated for Hodgkin's disease outside of Brigham and Women's Hospital or Dana-Farber Cancer Institute
  • Current age \< 15 years of age
  • Less than 5 years out from initial treatment
  • Relapses within 1 year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Hodgkin Disease

Condition Hierarchy (Ancestors)

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

Study Officials

  • Andrea K. Ng, MD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Radiation Oncology

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 14, 2005

Study Start

February 1, 2004

Primary Completion

October 1, 2007

Study Completion (Estimated)

December 1, 2028

Last Updated

September 10, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(2)