Clinical trial · Observational
The CAROLE (CArdiac Related Oncologic Late Effects) Study
NCT03235427CI-TRIAL-00038736CAROLEcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
CAROLE seeks to evaluate the relationship between chest Radiation Therapy and coronary artery disease. The purpose of CAROLE is to check the heart health of women who received breast cancer treatments in the past and protect them from future heart disease.
Conditions
Conditions (12)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Atherosclerotic Heart Disease | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Carcinoma, Intraductal, Noninfiltrating | Carcinoma | ONTOLOGY_EXACT | 0.85 |
| Cardiac Disease | — | UNRESOLVED | — |
| Cardiac Toxicity | — | UNRESOLVED | — |
| Cardiotoxicity | — | UNRESOLVED | — |
| Coronary Artery Disease | — | UNRESOLVED | — |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Radiation |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Received Radiation Therapy(RT)
- description
- Patients who had received radiotherapy will be sub-stratified into those who received treatment to the left or right breast.
- label
- Did not receive Radiation Therapy (RT)
- description
- Patients who did not receive radiation treatment, but received chemotherapy, hormonal therapy, and/or surgery will be used as study controls to compare the prevalence and burden of cardiac disease as compared to radiation patients.
Primary outcomes (3)
- measure
- Multimodality Cardiology Assessment- EKG
- timeFrame
- 1 Year
- description
- Assess whether radiation to the heart is associated with increased pre-clinical and clinical cardiac disease (as determined by a composite of multimodality cardiology assessments including EKG. Studies will be read using a standard, evidence based, set of criterion and documented using study templates) and compared to patients who did not receive radiation to the heart. All cardiac tests will be reviewed and reported as a composite with one the following; No evidence of disease/unrelated, preclinical disease, or clinical disease (non-numerically) based on the Cardiologists read of the study based on standard Pre-Specified criteria.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 26 Years
- Maximum age
- 78 Years
Show eligibility criteria text
Inclusion Criteria: * If you are a breast cancer survivor who was diagnosed between the ages of ≥ 18-65 years (now at age 26-78). * It has been at least 6 years since you were diagnosed. * If you did not have a diagnosis of heart disease before\* having breast cancer. * (\*women diagnosed with heart disease after breast cancer may still be eligible) Exclusion Criteria: * Patients who are unable to care for themselves or who are unable to come in for testing due to health conditions or incarceration will be rescheduled or removed in the case of chronic ineligibility. No vulnerable patient populations will be used in this study. Patients will be excluded if they have any pre-existing cardiac disease at the time of diagnosis of their breast cancer (2004-2011). * Pregnant and nursing women are ineligible.
References
Publications (15)
- BACKGROUNDAndersen R, Wethal T, Gunther A, Fossa A, Edvardsen T, Fossa SD, Kjekshus J. Relation of coronary artery calcium score to premature coronary artery disease in survivors >15 years of Hodgkin's lymphoma. Am J Cardiol. 2010 Jan 15;105(2):149-52. doi: 10.1016/j.amjcard.2009.09.005. Epub 2009 Nov 14. PMID 20102909
- BACKGROUNDCorrea CR, Litt HI, Hwang WT, Ferrari VA, Solin LJ, Harris EE. Coronary artery findings after left-sided compared with right-sided radiation treatment for early-stage breast cancer. J Clin Oncol. 2007 Jul 20;25(21):3031-7. doi: 10.1200/JCO.2006.08.6595. PMID 17634481
- BACKGROUNDChang 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 24093087
- BACKGROUNDSantoro F, Tarantino N, Pellegrino PL, Caivano M, Lopizzo A, Di Biase M, Brunetti ND. Cardiovascular sequelae of radiation therapy. Clin Res Cardiol. 2014 Dec;103(12):955-67. doi: 10.1007/s00392-014-0718-y. Epub 2014 May 7. PMID 24803132
- BACKGROUNDTjessem KH, Bosse G, Fossa K, Reinertsen KV, Fossa SD, Johansen S, Fossa A. Coronary calcium score in 12-year breast cancer survivors after adjuvant radiotherapy with low to moderate heart exposure - Relationship to cardiac radiation dose and cardiovascular risk factors. Radiother Oncol. 2015 Mar;114(3):328-34. doi: 10.1016/j.radonc.2015.01.006. Epub 2015 Jan 16. PMID 25600105
- BACKGROUNDNg AK. Review of the cardiac long-term effects of therapy for Hodgkin lymphoma. Br J Haematol. 2011 Jul;154(1):23-31. doi: 10.1111/j.1365-2141.2011.08713.x. Epub 2011 May 3. PMID 21539537
- BACKGROUNDFeng M, Moran JM, Koelling T, Chughtai A, Chan JL, Freedman L, Hayman JA, Jagsi R, Jolly S, Larouere J, Soriano J, Marsh R, Pierce LJ. Development and validation of a heart atlas to study cardiac exposure to radiation following treatment for breast cancer. Int J Radiat Oncol Biol Phys. 2011 Jan 1;79(1):10-8. doi: 10.1016/j.ijrobp.2009.10.058. Epub 2010 Apr 24.