Assessing the Impact of the Microbiome on Breast Cancer Radiotherapy Toxicity

  • STATUS
    Recruiting
  • End date
    Dec 22, 2023
  • participants needed
    50
  • sponsor
    Case Comprehensive Cancer Center
Updated on 22 October 2022
cancer
breast cancer
invasive breast cancer
ductal carcinoma in situ
breast-conserving surgery

Summary

Microorganisms in the human body (such as virus, bacteria, fungus) may have an important role in breast cancer side effects. In this study, microorganisms will be analyzed to determine which, if any,are present. It will then be determined if side effects from breast radiation are associated with these microorganisms. Understanding the association of microorganisms with side effects will allow the study team to look at strategies to reduce side effects for patients undergoing radiation to the breast.

Description

This study will prospectively enroll 50 participants with with biopsy proven Ductal carcinoma in situ (DCIS) or invasive breast cancer 18 years of age or older, undergoing breast conserving surgery and adjuvant radiation therapy at Cleveland Clinic.

Each participant will have a post-surgery pre-radiotherapy stool and breast skin sample obtained, complete a medical record review for clinical data, and have complete an interview/questionnaire in order to learn about potential risk factors which will be included in the data collection form. Included information will include Stage (T, N, M, composite), receipt of chemotherapy, radiation fields and dose, BMI, hypertension (HTN), Diabetes Mellitus (DM), smoking status, history of breast infection yes/no (Data Collection Form).

Details
Condition DCIS, Invasive Breast Cancer
Treatment stool sample, Skin Swab Sample
Clinical Study IdentifierNCT04245150
SponsorCase Comprehensive Cancer Center
Last Modified on22 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Breast cancer patients with DCIS or invasive breast cancer
Undergoing breast conserving surgery and adjuvant radiation
Subjects must be willing and able to provide breast skin samples

Exclusion Criteria

Active clinical breast infection (on antiobiotic for skin/breast infection or clinical diagnosis)
Refuse or are unable to sign informed consent form
Past history of breast cancer
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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