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The purpose of this study is to obtain data to determine whether whole breast irradiation (WBI) differentially influences the frequency of components of innate and adaptive immunity and their relative functional activity, to assess the patient's quality of life (QOL) and to evaluate the cosmetic assessment of the breast on follow-up after WBI treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blood Collection | Experimental | Patients will be asked to have blood draws at specific time points during their whole breast irradiation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood Draw | Diagnostic Test | Eligible subjects will have blood draws at the following times: baseline, 1 week, 4 weeks, 8 weeks, 12 weeks, 24 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lymphopenia | Incidence of lymphopenia | Up to 6 months after treatment |
| Cytokines | Change in patient's number of cytokines | Up to 6 months after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life | Changes in Patient-Reported Quality of Life using the EORTC QLQ-C30 | Up to 24 months after treatment |
| Cosmetic Changes | Changes in physician reported cosmetic descriptions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dena Snyder | Contact | 434-243-6899 | ds6he@virginia.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia | Recruiting | Charlottesville | Virginia | 22908 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Up to 24 months after treatment |
| Quality of Life | Changes in Patient-Reported Quality of Life using the EORTC QLQ-BR23. | Up to 24 months after treatment |
| Cosmetic Changes | Changes in patient reported cosmetic descriptions | Up to 24 months after treatment |
| D017437 |
| Skin and Connective Tissue Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |