NCT00903890

Brief Summary

This study is to inquire by mailed survey regarding the cardiac and general health of patients previously treated for Hodgkin's and non-Hodgkin's lymphoma with radiation therapy/anthracycline chemotherapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2008

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

Study Start

First participant enrolled

August 1, 2008

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 19, 2009

Completed
9.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 9, 2020

Completed
Last Updated

August 14, 2023

Status Verified

August 1, 2023

Enrollment Period

10.3 years

First QC Date

May 15, 2009

Last Update Submit

August 10, 2023

Conditions

Hodgkin DiseaseLymphoma, Non-Hodgkin

Outcome Measures

Primary Outcomes (2)

  • Measure changes in Cardiac ejection fraction score

    Post Radiation Treatment

  • Measure changes in perfusion imaging score on the radionuclide cardiac profusion scan

    Post Radiation

Study Arms (1)

A

Individuals who have previously received radiation therapy and anthracycline chemotherapy for their Hodgkin's or non-Hodgkin's lymphoma.

Other: Survey

Interventions

SurveyOTHER

Survey asking questions regarding the subjects cardiac and general health.

A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients previously treated at the University of Rochester Department of Radiation Oncology.

You may qualify if:

  • All patients with Hodgkin's Lymphoma and Non Hodgkin's lymphoma who underwent Radiation Therapy (RT) to either a mantle or modified mantle field with or without adriamycin at the Wilmot Cancer Center at the University of Rochester are eligible for the study.

You may not qualify if:

  • Any severe preexisting cardiac disease (e.g., arrhythmia, angina, coronary disease, myocardial infarction, or congestive heart failure) prior to diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Hodgkin DiseaseLymphoma, Non-Hodgkin

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Louis S Constine, MD

    University of Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 15, 2009

First Posted

May 19, 2009

Study Start

August 1, 2008

Primary Completion

November 1, 2018

Study Completion

April 9, 2020

Last Updated

August 14, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)