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Tumor Integrating Gut Microbiota in bREast Cancer

NCT07253168 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2025-11-28

No results posted yet for this study

Summary

Study on patients undergoing surgery for breast cancer. Objective: to characterize the intratumoral microbiota and integrate these findings with clinicopathologic data, the estrobolome, and gut microbiota, with analyses stratified by molecular subtype (Luminal A, Luminal B, HER2-enriched \[human epidermal growth factor receptor 2-enriched\], and TNBC \[triple-negative breast cancer\]).

Enrollment: consecutive recruitment in the operating room based on the availability of biopsy/histological material.

Samples: tumor tissue, adjacent normal tissue; urine (for indirect assessment of estrobolome activity); and stool. Strict anti-contamination measures will be implemented.

Exploratory outcomes: differences across subtypes, associations with features of the TME (tumor microenvironment), including TILs (tumor-infiltrating lymphocytes), and markers of progression or treatment resistance

Conditions

Interventions

PROCEDURE

Surgery for breast cancer

To investigate the intratumoral microbiota in breast cancer and integrate these findings with gut microbiota analyses, including estrobolome characterization, to explore potential microbial-host interactions influencing tumor biology across molecular subtypes

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Brunella Posteraro · Fondazione Policlinico Universitario A. Gemelli, IRCCS

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-01
Primary Completion
2027-12-01
Completion
2028-12-01

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07253168 on ClinicalTrials.gov