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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
Sponsor:
Information provided by (Responsible Party):
Shayna Showalter, MD, University of Virginia

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Diagnostic Test: Blood Draw Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Lymphopenia [ Time Frame: Up to 6 months after treatment ]
    Incidence of lymphopenia

  2. Cytokines [ Time Frame: Up to 6 months after treatment ]
    Change in patient's number of cytokines


Secondary Outcome Measures :
  1. Quality of Life [ Time Frame: Up to 24 months after treatment ]
    Changes in Patient-Reported Quality of Life using the EORTC QLQ-C30

  2. Cosmetic Changes [ Time Frame: Up to 24 months after treatment ]
    Changes in physician reported cosmetic descriptions

  3. Quality of Life [ Time Frame: Up to 24 months after treatment ]
    Changes in Patient-Reported Quality of Life using the EORTC QLQ-BR23.

  4. Cosmetic Changes [ Time Frame: Up to 24 months after treatment ]
    Changes in patient reported cosmetic descriptions


Eligibility Criteria
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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Willingness and ability to provide written informed consent and to comply with the study protocol as judges by the investigator.
  • Patient has new diagnosis of breast cancer and has elected BCS and WBI. These patients must be consented prior to the start of WBI.
  • For patients with invasive breast cancer sentinel node biopsy (SLNB) must be performed and confirm pathologic negative disease.
  • Tumor size must be less than or equal to 3 cm.
  • Patient is 45 years of age or older.
  • Women of childbearing potential must agree to use adequate contraception prior to study entry and through the WBI treatment. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

Exclusion Criteria:

  • Male patients
  • Patients who are pregnant or nursing.
  • Patient has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the duration of the study or is not in the best interest of the patient to participate, in the opinion of the treating investigator.
  • Breast cancer that involves the skin or the chest wall.
  • History of ipsilateral breast cancer treated with radiation therapy.
  • Multicentric breast cancer in the ipsilateral breast as diagnosed by clinical exam, mammogram, ultrasound, or MRI
  • Patients known to have a BRCA gene mutation. Genetic testing is not required.
  • Patient with clinically positive nodal disease.
  • Patient with proven nodal disease by either FNA, core biopsy or sentinel node biopsy.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Dena Snyder 434-243-6899 ds6he@virginia.edu

Locations
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United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Dena Snyder         
Principal Investigator: Shayna Showalter, MD         
Sponsors and Collaborators
University of Virginia
More Information
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Responsible Party: Shayna Showalter, MD, MD, Assistant Professor of Medicine, University of Virginia, University of Virginia
ClinicalTrials.gov Identifier: NCT03567044    
Other Study ID Numbers: 20476
First Posted: June 25, 2018    Key Record Dates
Last Update Posted: June 25, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases