Trial Title:
Understanding CARdiac Events in Breast Cancer
NCT ID:
NCT05921279
Condition:
Breast Cancer
Cardiotoxicity
Cardiomyopathies
Chemotherapeutic Toxicity
Heart Failure
Oncology
Conditions: Official terms:
Breast Neoplasms
Neoplasms
Cardiomyopathies
Cardiotoxicity
Cardiovascular Diseases
Conditions: Keywords:
Cardio oncology
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Summary:
In Ireland, over 3,000 patients are diagnosed with breast cancer annually, and 1 in 9
Irish women will be diagnosed with breast cancer in their lifetime. There is evidence
that female breast cancer survivors are more likely to die of cardiovascular disease than
their age-matched counterparts.
This research is focused on evaluating pathways for identifying, managing, and overcoming
side effects of cancer therapies that can negatively impact quality-of-life and overall
outcomes for women during and after cancer treatment. The Cardio-oncology research team
at GUH plan to capitalize on their expertise in both cancer care and cardiology to
develop a care pathway for cancer patients who are at increased risk of developing heart
disease.
Detailed description:
Establishment of a Cardio-Oncology assessment and surveillance pathway for breast cancer
patients undergoing adjuvant systemic chemotherapy at GUH and the assessment of the
feasibility of trialing this approach for risk assessment and early detection of CTRCD in
a multicenter, prospective RCT which will inform future development of clinical services
for cancer patients nationally and later internationally.
Study Design:
This study is a prospective, single arm, pilot feasibility study.
Study Population:
The study will focus on adult female patients diagnosed with stage I-III breast cancer
(BC).
Data Analysis and Statistics:
The PCORE Investigators have established collaboration with biostatisticians at the
INSIGHT SFI centre for data analytics within University of Galway for analysis of the
multi-component dataset from UCARE. Questionnaire data to assess health related QoL
(quality of life) and physical activity will be collected at baseline and at 6-monthly
intervals at 3, 6 and 12 months throughout the study period. Clinically important
differences in physical activity levels or HR-QoL scores will be recorded as per the tool
specific scoring systems. Multivariate analysis will be performed for association between
HRQoL measures and predictors in patients undergoing breast cancer treatment. Baseline to
6, 12, 18 and 24 month changes in HRQoL over time will be described in subgroups defined
by their treatment characteristics and tumor and host response to therapy (both oncologic
and cardio-toxic).
Criteria for eligibility:
Study pop:
Adult female patients diagnosed with stage I-III breast cancer receiving chemotherapy.
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
- Women aged ≥ 18 years
- Ability to read and understand English
- Breast Cancer Stage I- III planned to receive systemic chemotherapy
Exclusion Criteria:
- Patients not for systemic chemotherapy with curative intent
- Patients who are unable to co-operate with the study protocol
- Patients who are unable to give informed consent
Gender:
Female
Gender based:
Yes
Gender description:
Female
Minimum age:
18 Years
Maximum age:
90 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Galway University Hospital
Address:
City:
Galway
Zip:
H91 T861
Country:
Ireland
Status:
Recruiting
Contact:
Last name:
Osama Soliman, MBBCH, PHD
Phone:
+35391493781
Email:
osama.soliman@universityofgalway.ie
Contact backup:
Last name:
Aoife Lowery, MBBS, PhD
Investigator:
Last name:
Osama Soliman, MB BCh,PhD
Email:
Principal Investigator
Investigator:
Last name:
Aoife Lowery, MB BCh, PhD
Email:
Principal Investigator
Investigator:
Last name:
Veronica McInerney, MD,PhD
Email:
Sub-Investigator
Investigator:
Last name:
William Wijns, MD, PhD
Email:
Principal Investigator
Investigator:
Last name:
Michael Kerin, MD, PhD
Email:
Principal Investigator
Investigator:
Last name:
Maccon Keane, MD,PhD
Email:
Principal Investigator
Investigator:
Last name:
Silvie Blazkova, MB BCh
Email:
Principal Investigator
Facility:
Name:
Galway Clinic
Address:
City:
Galway
Country:
Ireland
Status:
Recruiting
Facility:
Name:
Mayo University Hospital
Address:
City:
Mayo
Country:
Ireland
Status:
Recruiting
Facility:
Name:
Sligo General Hospital
Address:
City:
Sligo
Country:
Ireland
Status:
Recruiting
Start date:
January 14, 2023
Completion date:
July 2026
Lead sponsor:
Agency:
National University of Ireland, Galway, Ireland
Agency class:
Other
Collaborator:
Agency:
Clinical Research Facility Galway
Agency class:
Other
Collaborator:
Agency:
CORRIB Research Centre for Advanced Imaging and Core Lab, Galway, Ireland
Agency class:
Other
Source:
National University of Ireland, Galway, Ireland
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05921279
