NCT05020574 Microbiome and Association With Implant Infections
| NCT ID | NCT05020574 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of California, San Francisco |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2021-09-28 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 200 participants in total. It began in 2021-09-28 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The most common tissue expander-related infections are from Staphylococcus and Pseudomonas species. In addition, from breast tissue microbiome studies, Staphylococcus and Pseudomonas show variable abundance across samples. The investigator hypothesizes that participants undergoing mastectomy with high initial abundance of Staphylococcus and/or Pseudomonas are more likely to develop subsequent tissue expander-related infections from these respective organisms.
Eligibility Criteria
Inclusion Criteria: 1. Patients must have histologically confirmed breast malignancy OR genetic predisposition to breast cancer. 2. Age \>= 18 years 3. Scheduled to undergo mastectomy with the immediate placement of tissue expanders or implant placement 4. Ability to understand a written informed consent document, and the willingness to sign it 5. At least 4 weeks post-completion of chemotherapy or radiation therapy. Exclusion Criteria: 1. Any significant medical condition or laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study 2. Pregnant or breastfeeding 3. Patients who have taken antibiotics within 90 days of the consent date 4. Patients who have taken probiotics within 90 days of the consent date 5. Patients who have a documented or reported allergic reaction to the outlined antibiotics to be used in this study 6. Male patients
Contact & Investigator
Merisa Piper, MD
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT05020574 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05020574 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05020574 currently recruiting?
Yes, NCT05020574 is actively recruiting participants. Contact the research team at Laura.Barnes@ucsf.edu for enrollment information.
Where is the NCT05020574 trial being conducted?
This trial is being conducted at San Francisco, United States.
Who is sponsoring the NCT05020574 clinical trial?
NCT05020574 is sponsored by University of California, San Francisco. The principal investigator is Merisa Piper, MD at University of California, San Francisco. The trial plans to enroll 200 participants.
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