Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
25 participants
OBSERVATIONAL
2022-03-29
2026-04-30
Brief Summary
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Detailed Description
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Secondary Objective
* To correlate gut microbiome populations with circulating sex hormone metabolite concentrations at baseline and 12 weeks.
* To describe the correlation of change in the microbiome populations with change in circulating sex hormone metabolite concentrations from baseline to 12 weeks.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Aromatase inhibitor for breast cancer treatment
Participants will receive their standard of care for breast cancer treatment which includes an aromatase inhibitor. Pre-study assessments will be done at baseline as well as stool and blood samples at baseline, then again at 4 weeks and at 12 weeks during the course of the trial.
Fecal swab collection
Participants will collect fecal sample at home and either mail in the sample, or drop it off at the lab
Blood samples
Participants will have approximately 1 teaspoon of blood withdrawn from a vein, for research, on 2 different occasions. The total amount of blood withdrawn during the study will be approximately 2 teaspoons.
Interventions
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Fecal swab collection
Participants will collect fecal sample at home and either mail in the sample, or drop it off at the lab
Blood samples
Participants will have approximately 1 teaspoon of blood withdrawn from a vein, for research, on 2 different occasions. The total amount of blood withdrawn during the study will be approximately 2 teaspoons.
Eligibility Criteria
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Inclusion Criteria
* ECOG performance status 0,1, 2, 3.
* Age ≥ 18 years
* HER2+ breast cancer is allowed if patients are on a monoclonal antibody therapy for which a change is not anticipated while on study (12 weeks) and they have been on the monoclonal antibody therapy for at least 4 weeks.
* Ability to read, understand and evaluate study materials and willingness to sign a written informed consent document.
Exclusion Criteria
* Administered chemotherapy less than 4 weeks prior to enrollment.
* Hormone replacement (defined as only estrogen and/or progesterone replacement) or anti-estrogen therapy within 4 weeks of starting aromatase inhibitors
* Use of antibody drug conjugate (HER2+ breast cancer)
* Male breast cancer
* Any serious and/or unstable pre-existing medical, psychiatric, or other existing condition that would prevent compliance with the trial or consent process
18 Years
FEMALE
No
Sponsors
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Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Katherine Ansley, MD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest Baptist Health Sciences
Locations
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Wake Forest Baptist Health Sciences
Winston-Salem, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Study Coordinator
Role: primary
Other Identifiers
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WFBCCC 74121
Identifier Type: OTHER
Identifier Source: secondary_id
IRB00076577
Identifier Type: -
Identifier Source: org_study_id