NCT05775822Completed
Coronary Artery Calcium and Cardiovascular Risk Factors Analysis After RT or Breast Cancer
Coronary Artery Calcium and Cardiovascular Risk Factors Analysis After RT for Breast Cancer. A Gender-based Preventive Medicine Approach
Source: ClinicalTrials.gov · Last updated 7 Feb 2024
Brief summary (registry, in English)
This is a no-profit, national, monocenter, retrospective, and prospective low-intervention study. It is a low-intervention study in terms of diagnostic additional procedure (CT scan). It is planned to recruit a maximum of 100 women diagnosed with early-stage breast cancer and treated with adjuvant breast radiotherapy from 2010 to 2017 at the European Institute of Oncology who meet all the inclusion and exclusion criteria. The aim of the Study is to analyze a population of breast cancer patients treated by adjuvant whole breast radiotherapy to identify the most important cardiovascular (CV) risk factors linked to coronary artery disease (CAD) development, in a cure-without-complications oncology strategy.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 92 (actual)
- First submitted
- 17 Feb 2023
- Start date
- 24 Mar 2022
- Primary completion date
- 20 Dec 2023
- Lead sponsor
- Centro Cardiologico Monzino
- Diseases
- Coronary artery disease
- NCT number
- NCT05775822
What you commit to
- Study type: Interventional
- Participants enrolled: 92
- From 24 Mar 2022 to the primary completion date, 20 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with a prior diagnosis of invasive cancer (apart from non-melanoma skin cancer);
- Patients with no definitive surgery (e.g. a biopsy only);
- Patients who did not receive radiotherapy were excluded from the Study.
- IORT (Intraoperative radiotherapy) and PBI (partial breast radiotherapy) excluded
Other illness
- Patients with bilateral breast cancer or breast cancer of unknown laterality;
- Patients with known active ischemic heart disease during or before the RT period;
- Participants not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to Study procedures
Age
- Patients aged \< 18 or \> 60 years at time of radiation therapy;
Other
- Patients who are currently participating in an investigational interventional study.
Who the study is looking for
- Women diagnosed with early-stage breast cancer treated with adjuvant whole breast external beam radiotherapy from 2010 to 2017;
- Patients with a \> 5 years clinical follow-up (FU) from diagnosis of breast cancer
- Adult women/patients ≥18 years old and ≤ 60 years at time of radiation therapy;
- Patients with homogeneous and standardized radiation exposure protocol (external beam radiotherapy 40 Gy in 15 fractions)
- Patients who have signed the written informed consent
Age in the registry: 18 years to 60 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS Centro Cardiologico Monzino Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.