Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: Nil: Nil
Intervention3: Nil: Nil
Intervention4: Nil: Nil
Intervention5: Nil: Nil
Sponsors
Richa Sharma
Eligibility
Inclusion criteria
Inclusion criteria: Diagnosis: Individuals diagnosed with invasive breast carcinoma confirmed through resected specimen. Age: participants aged 35-85 yrs. diagnosed with invasive breast carcinoma. Consent: participants who have given informed consent. Samples with sufficient tissue for analysis
Exclusion criteria
Exclusion criteria: Previous Treatment: individuals who have undergone previous treatment for breast cancer, such as surgery, chemotherapy, or radiation therapy, as these may influence mast cell density. Other Cancers: individuals with a history of other malignancies to focus specifically on breast carcinoma. Immunodeficiency: individuals with known immunodeficiency conditions, as this may impact the immune response and mast cell activity. Pregnancy: pregnant individuals due to potential hormonal influences on mast cells.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate whether mast cell density (MCD) correlates with tumor behavior in breast carcinoma, especially in relation to: Tumor grade Hormone receptor status (ER/PR) Lymph node involvement Histological features (tubule formation, nuclear pleomorphism, mitotic count) And to determine if MCD can serve as an independent or superior predictive marker compared to existing histopathological parameters.Timepoint: Outcomes will be assessed once per case, immediately after completion of all histopathological (H&E), immunohistochemical (ER, PR, HER2, Ki-67), and toluidine blue staining procedures. As this is a retrospective study, each specimens outcome will be evaluated at a single point in time, post-laboratory processing. Final data analysis will be performed continuously during the 2-year study period as and when each cases results are completed. | — |
Secondary
| Measure | Time frame |
|---|---|
| Association between mast cell density (MCD) & tumor grade Correlation of MCD with hormone receptor status (ER/PR positivity) Relationship between MCD & lymph node involvement Correlation of MCD with mitotic index & nuclear pleomorphismTimepoint: Secondary outcomes will be assessed once per case at baseline, defined as the time of histopathological diagnosis. Correlation of mast cell density with ER/PR status, lymph node involvement, mitotic index, & nuclear pleomorphism will be done at this single time point using data from mastectomy specimens. | — |
Countries
India
Contacts
Public ContactRicha Sharma
Datta Meghe Institute of Higher Education and Research
Outcome results
None listed