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To understand the effects induced by acute hypoxia that sets in during surgery in breast cancer. To study this, clinical samples (Tumor biopsies) will be obtained during the surgery after partial devascularisation (sample B) and stored for future genomic and proteonomic evaluations.
Three tumor samples will be obtained after the patient is under anaesthesia,
To understand the effects induced by acute hypoxia that sets in during surgery in breast cancer. To study this, clinical samples (Tumor biopsies) will be obtained during and stored for future genomic and proteonomic evaluations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intra-operative tumour tissue biopsies | Intra-operative tumour tissue biopsies will be collected for all patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intra-operative Tumor Tissue Biopsy | Procedure | The changing pattern of gene expression during surgery has never been studied. This could be an effect of acute hypoxia that sets in the tumour during surgery or could be a surgical response. To study these changes happening in the tumour during surgery, we are taking serial biopsies during surgery, one at the beginning, one midway during surgery and one at the end of surgery. These samples will be snap frozen and stored at -80 deg celsius in biorepository for future analysis. |
| Measure | Description | Time Frame |
|---|---|---|
| Gene expression changes | The primary outcome measured will be gene expression changes during surgical resection. Messenger ribonucleic acid (mRNA) transcripts will be quantitated and their levels evaluated during different time-points of surgical resection, using high throughput omics technologies (Next generation sequencing, nanostring ncounter, qRT-PCR array). | The study aims to evaluate gene expression changes during surgical resection, which lasts for 30-90 minutes on an average. Thus, we have not planned a clinical follow-up or collection of data for the patients post sampling during surgical resection. |
| Measure | Description | Time Frame |
|---|---|---|
| Immunohistochemistry for other markers | The secondary outcome measured will be protein expression changes during surgical resection. Protein levels will be quantitated, and their levels evaluated, during different time-points of surgical resection. Transcripts found to be de-regulated or changed at different time-points of surgical resection will be evaluated using IHC at protein level. We will also use high throughput omics technologies (SILAC, ITRAQ) for characterising these changes at protein levels. |
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Inclusion Criteria:
Exclusion Criteria:
Women diagnosed with breast cancer, undergoing surgery upfront
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Women diagnosed with breast cancer at outpatient clinic
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shalaka Joshi, MS, MCh | Contact | 9869089803 | 4265 | drjoshishalaka@gmail.com |
| Rohini A Hawaldar | Contact | 09820432613 | rwhawaldar@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Rajendra Badwe | Director, tata Memorial Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tata Memorial Center | Recruiting | Mumbai | Maharashtra | 400012 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23222717 | Background | Semenza GL. Cancer-stromal cell interactions mediated by hypoxia-inducible factors promote angiogenesis, lymphangiogenesis, and metastasis. Oncogene. 2013 Aug 29;32(35):4057-63. doi: 10.1038/onc.2012.578. Epub 2012 Dec 10. | |
| 11395851 | Background | Hockel M, Vaupel P. Biological consequences of tumor hypoxia. Semin Oncol. 2001 Apr;28(2 Suppl 8):36-41. |
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Breast cancer tumor tissue
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| The study aims to evaluate gene expression changes during surgical resection, which lasts for 30-90 minutes on an average. Thus, we have not planned a clinical follow-up or collection of data for the patients post sampling during surgical resection. |
| 23915189 | Background | Hoesel B, Schmid JA. The complexity of NF-kappaB signaling in inflammation and cancer. Mol Cancer. 2013 Aug 2;12:86. doi: 10.1186/1476-4598-12-86. |
| 41934415 | Derived | Gardi N, Chaubal R, Gandhi KA, Kadam A, Singh A, Raja AS, Vanmali V, Hawaldar R, Sale S, Joshi S, Badwe R, Gupta S. Clinically actionable alterations in Indian breast cancer patients derived through whole transcriptome sequencing. Indian J Med Res. 2026 Jan;163(1):95-103. doi: 10.25259/IJMR_1642_2024. |