AtherosclerosisABCARTNCT00960401
A Study of Atherosclerosis in Patients After Radiation Treatment for Breast Cancer
An observational study of Atherosclerosis, run by Winthrop University Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Jan 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: breast cancer patients after radiation treatment
Who may be able to join
- 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
Who cannot join
- hx of coronary disease prior to tx of ductal carcinoma in situ or breast cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
Winthrop University Hospital
Mineola, New York, 11501
About this study
Official title: Pilot Study "A Study of Atherosclerosis in Patients After Radiation Treatment for Breast Cancer"
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.
Read the detailed description
This study reviews case series of patients with a history of breast cancer treated with radiotherapy for at least five years. The study measures atherosclerosis by using coronary and carotid artery calcium scoring.
- Conditions
- Atherosclerosis
- Keywords
- coronary calcium scoring, breast cancer patients, radiation treatment
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Analyzed for Coronary Calcium Burden by AGS
Number of participants who received a coronary calcium scan.
Measured: Year 5 Post-Initiation of Radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2009 (estimated)
- Study startAug 2005
- Primary completionMay 2007
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Winthrop University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander Hindenburg, MD, Principal investigator, Winthrop University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00960401
- Sponsor's protocol ID
- 05018
- Acronym
- ABCART
- Status last verified
- Feb 2023
- First submitted
- 13 Aug 2009
- Last updated
- 27 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 24093087
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study "A Study of Atherosclerosis in Patients After Radiation Treatment for Breast Cancer"
- ClinicalTrials.gov ID
- NCT00960401
- Acronym / sponsor ID
- ABCART / 05018
- Conditions
- Atherosclerosis
- Keywords
- coronary calcium scoring, breast cancer patients, radiation treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Winthrop University HospitalUniversity, hospital or other
- Study start
- Aug 2005
- Primary completion
- May 2007 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 17 Aug 2009 (estimated)
- Results
- Posted 27 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study reviews case series of patients with a history of breast cancer treated with radiotherapy for at least five years. The study measures atherosclerosis by using coronary and carotid artery calcium scoring.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- breast cancer patients after radiation treatment
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- hx of coronary disease prior to tx of ductal carcinoma in situ or breast cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants Analyzed for Coronary Calcium Burden by AGS
Time frame: Year 5 Post-Initiation of Radiotherapy
Number of participants who received a coronary calcium scan.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24093087Chang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Hindenburg, MD principal investigator
Winthrop University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerosis, run by Winthrop University Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Analyzed for Coronary Calcium Burden by AGS (time frame: Year 5 Post-Initiation of Radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00960401, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2023.