Spatial Profiling of Tumor Micro-environment in Postpartum Breast Cancer Implications for Prognosis and Targeted Therapies
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Identification of distinct spatial gene expression patterns and immune/stromal signatures in postpartum breast cancer (PPBC) tumors using spatial profiling that are associated with poor clinical outcomes (e.g., recurrence, metastasis, or reduced overall survival).
研究概览
简要总结
This study (retrospective observational/experimental study) will be conducted in St. John’s Research Institute, Bangalore, India under the LMIC mentor Dr. Jyothi S Prabhu, Faculty, Division of Molecular medicine, St. John’s Research Institute.This project aims to investigate the unique tumor micro-environment (TME) of postpartum breast cancer (PPBC) samples already collected from women under 45 years of age using archived FFPE (formalin fixed paraffin embedded) tissue and clinical data. Treatment-naïve primary tumor samples will be selected from an existing breast cancer cohort. Spatial profiling will be performed to characterize immune and stromal cell distribution within the TME. Clinical, reproductive, and pathological data will be integrated to identify PPBC-specific features. Key biomarkers identified through spatial profiling will be validated using multiplex immuno-histochemistry (mIHC). Comparative analysis will be conducted between PPBC and non-PPBC cases to uncover differentially enriched immune pathways or cell types. Long-term follow-up data will be used to assess the prognostic significance of these biomarkers in stratifying high-risk patients. Only de-identified data will be securely shared with the U.S. mentor as part of this NIH Fogarty INSIGHT Fellowship. The study adheres strictly to ethical guidelines and poses minimal risk to participants as it is retrospective study performed only on the already collected tissue samples.
Samples for this study have been collected from a breast cancer patient cohort referenced in these publications:
Nimbalkar VP, Snijesh VP, Rajarajan S, Anupama CE, Mahalakshmi S, Alexander A, Dechamma D, Moorthy M, Ramaswamy G, Ramesh R, Srinath BS, Prabhu JS. Spatial profiling reveals unique immune microenvironment in premenopausal triple-negative breast cancer associated with therapy response. J Transl Med. 2025 Jul 10;23(1):761. doi: 10.1186/s12967-025-06786-8. PMID: 40640880; PMCID: PMC12243298.
Nimbalkar VP, Snijesh VP, Rajarajan S, Alexander A, Kaluve R, Ramesh R, Srinath BS, Prabhu JS. Premenopausal women with breast cancer in the early post-partum period show molecular profiles of invasion and are associated with poor prognosis. Breast Cancer Res Treat. 2023 Jul;200(1):139-149. doi: 10.1007/s10549-023-06956-6. Epub 2023 May 9. PMID: 37160509; PMCID: PMC10224850.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Tumor samples obtained from a previously collected breast cancer tissue cohort in the laboratory.
- •Primary treatment naïve Breast Cancer patients under 45 years with information on childbirth, clinicopathological features and follow up on disease outcome will be included.
排除标准
- •NACT Neo adjuvant chemotheraphy, Missing childbirth information, Patients above 45 years.
结局指标
主要结局
Identification of distinct spatial gene expression patterns and immune/stromal signatures in postpartum breast cancer (PPBC) tumors using spatial profiling that are associated with poor clinical outcomes (e.g., recurrence, metastasis, or reduced overall survival).
时间窗: The duration of the primary Outcome will be Nine Months. | Total Study Duration twelve Months.
次要结局
- Validation of key biomarkers using multiplex immunohistochemistry mIHC Comparison of tumor microenvironment between PPBC post partum breast cancer and nonPPBC patients(Evaluation of biomarkers prognostic value for identifying high risk PPBC patients)
研究者
Dr Vidya P Nimbalkar
St Johns Research Institute Bengaluru