RECRUITING

Microbiome and Association With Implant Infections

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Conditions

Breast CancerBreast Cancer FemaleGenetic Predisposition to DiseasePost-Surgical AntibioticsBreast Implant InfectionsBreast MicrobiomeBreast ReconstructionMastectomy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Microbiome and Association With Implant Infections: Investigating the Impact of Antibiotics on the Gut and Breast Microbiomes Post-mastectomy With Implant-based Breast Reconstruction

Quick Facts

Study Start:2021-09-28
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05020574

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Patients must have histologically confirmed breast malignancy OR genetic predisposition to breast cancer.
  2. 2. Age \>= 18 years
  3. 3. Scheduled to undergo mastectomy with the immediate placement of tissue expanders or implant placement
  4. 4. Ability to understand a written informed consent document, and the willingness to sign it
  5. 5. At least 4 weeks post-completion of chemotherapy or radiation therapy.
  1. 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. 2. Pregnant or breastfeeding
  3. 3. Patients who have taken antibiotics within 90 days of the consent date
  4. 4. Patients who have taken probiotics within 90 days of the consent date
  5. 5. Patients who have a documented or reported allergic reaction to the outlined antibiotics to be used in this study
  6. 6. Male patients

Contacts and Locations

Study Contact

Laura Barnes, MD
CONTACT
(415) 502-1259
Laura.Barnes@ucsf.edu

Principal Investigator

Merisa Piper, MD
PRINCIPAL_INVESTIGATOR
University of California, San Francisco

Study Locations (Sites)

University of California, San Francisco
San Francisco, California, 94143
United States

Collaborators and Investigators

Sponsor: University of California, San Francisco

  • Merisa Piper, MD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-09-28
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2021-09-28
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

  • Post-Surgical Antibiotics
  • Breast Implant Infections
  • Breast Microbiome
  • Breast Reconstruction
  • Mastectomy

Additional Relevant MeSH Terms

  • Breast Cancer
  • Breast Cancer Female
  • Genetic Predisposition to Disease