Immune Effects in Patients Treated With Whole Breast Irradiation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03567044|
Recruitment Status : Unknown
Verified June 2018 by Shayna Showalter, MD, University of Virginia.
Recruitment status was: Recruiting
First Posted : June 25, 2018
Last Update Posted : June 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Diagnostic Test: Blood Draw||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Outcomes and Immune Effects in Patients With Early Stage Breast Cancer Treated With Lumpectomy and Whole Breast Irradiation.|
|Estimated Study Start Date :||October 1, 2018|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||March 2020|
Experimental: Blood Collection
Patients will be asked to have blood draws at specific time points during their whole breast irradiation.
Diagnostic Test: Blood Draw
Eligible subjects will have blood draws at the following times: baseline, 1 week, 4 weeks, 8 weeks, 12 weeks, 24 weeks.
- Lymphopenia [ Time Frame: Up to 6 months after treatment ]Incidence of lymphopenia
- Cytokines [ Time Frame: Up to 6 months after treatment ]Change in patient's number of cytokines
- Quality of Life [ Time Frame: Up to 24 months after treatment ]Changes in Patient-Reported Quality of Life using the EORTC QLQ-C30
- Cosmetic Changes [ Time Frame: Up to 24 months after treatment ]Changes in physician reported cosmetic descriptions
- Quality of Life [ Time Frame: Up to 24 months after treatment ]Changes in Patient-Reported Quality of Life using the EORTC QLQ-BR23.
- Cosmetic Changes [ Time Frame: Up to 24 months after treatment ]Changes in patient reported cosmetic descriptions
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03567044
|Contact: Dena Snyderfirstname.lastname@example.org|
|United States, Virginia|
|University of Virginia||Recruiting|
|Charlottesville, Virginia, United States, 22908|
|Contact: Dena Snyder|
|Principal Investigator: Shayna Showalter, MD|