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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients undergoing surgery for breast cancer | Experimental | single-arm discovery study with consecutive enrollment of eligible patients undergoing surgery for primary breast cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgery for breast cancer | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Breast cancer-associated microbial signatures | To characterize intratumoral microbial signatures (composition and inferred function) across breast cancer (BC) molecular subtypes (Luminal A, Luminal B, HER2-enriched, TNBC) using contamination-aware pipelines | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of microbial signatures | To compare microbial signatures between tumor and adjacent normal tissue (paired design) | 12 months |
| Association between microbial and host features | To explore associations between intratumoral microbial features and clinicopathologic and host variables |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brunella Posteraro | Contact | +3906030157959 | brunella.posteraro@unicatt.it |
| Name | Affiliation | Role |
|---|---|---|
| Brunella Posteraro | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Principal Investigator |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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|
|
| 12 months |
| D017437 |
| Skin and Connective Tissue Diseases |