NCT00960401

Brief Summary

The purpose of this study is to compare plaque burden in the coronary and carotid arteries 5 years after adjuvant radiotherapy in women with right sided breast cancer vs left sided breast cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2005

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, 2005

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

August 13, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 17, 2009

Completed
4.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
9.9 years until next milestone

Results Posted

Study results publicly available

November 27, 2023

Completed
Last Updated

November 27, 2023

Status Verified

February 1, 2023

Enrollment Period

1.7 years

First QC Date

August 13, 2009

Results QC Date

January 27, 2016

Last Update Submit

February 17, 2023

Conditions

Keywords

coronary calcium scoringbreast cancer patientsradiation treatment

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Analyzed for Coronary Calcium Burden by AGS

    Number of participants who received a coronary calcium scan.

    Year 5 Post-Initiation of Radiotherapy

Study Arms (2)

cardiac counseling

10 left sided breast cancer patients 10 right sided breast cancer patients

coronary artery evaluation

10 left sided breast cancer 10 right sided breast cancer

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

breast cancer patients after radiation treatment

You may qualify if:

  • women dx with ductal carcinoma in situ or breast cancer, stage 0 to stage IIIc, who received conservative surgery and radiotherapy at least 5 years ago
  • less than or equal to age 60

You may not qualify if:

  • hx of coronary disease prior to tx of ductal carcinoma in situ or breast cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

Related Publications (1)

  • Chang M, Suh J, Kirtani V, Dobrescu A, Haas J, Zeldis S, Shayani S, Hindenburg AA. Coronary Calcium Scanning in Patients after Adjuvant Radiation for Early Breast Cancer and Ductal Carcinoma In situ. Front Oncol. 2013 Sep 25;3:253. doi: 10.3389/fonc.2013.00253. eCollection 2013.

    PMID: 24093087BACKGROUND

MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
Dr. Alexander Hindenburg
Organization
Winthrop-University Hospital, Division of Hematology and Oncology

Study Officials

  • Alexander Hindenburg, MD

    Winthrop University Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2009

First Posted

August 17, 2009

Study Start

August 1, 2005

Primary Completion

May 1, 2007

Study Completion

January 1, 2014

Last Updated

November 27, 2023

Results First Posted

November 27, 2023

Record last verified: 2023-02

Locations