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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NOT_YET_RECRUITING
NA
240 participants
INTERVENTIONAL
2025-12-01
2028-12-01
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Patients undergoing surgery for breast cancer
single-arm discovery study with consecutive enrollment of eligible patients undergoing surgery for primary breast cancer
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Availability of sufficient tumor and adjacent normal tissue for research purposes after completion of diagnostic sampling.
* Written informed consent
Exclusion Criteria
* Antibiotics within 14 days pre-sampling (recorded; analyses adjusted).
* Prior ipsilateral BC surgery for current lesion (except re-excision with fresh tissue).
* Any condition preventing compliance with the study protocol.
18 Years
FEMALE
No
Sponsors
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
OTHER
Responsible Party
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Principal Investigators
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Brunella Posteraro
Role: PRINCIPAL_INVESTIGATOR
Fondazione Policlinico Universitario A. Gemelli, IRCCS
Central Contacts
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Other Identifiers
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8051
Identifier Type: -
Identifier Source: org_study_id
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