A Prospective Evaluation of the Peri-operative Hypoxia in Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intra-operative Tumor Tissue Biopsy.
- Who it may be relevant to
- Registry conditions: Breast Cancer Female. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- India
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Detailed description
Three tumor samples will be obtained after the patient is under anaesthesia,
1. Prior to starting surgery (Sample A) 2. The middle intra-operative sample, which will be collected when half the tumour has been devascularized (i.e., somewhere midway during the surgery). (Sample B) 3. A third post excision (anoxic sample C). These tumour tissue samples will be stored as snap frozen, in RNA later and as paraffin sections.
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.
Interventions
- Procedure Intra-operative Tumor Tissue Biopsy
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.
Primary outcome measures
- Gene expression changes [Time frame: 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.]
Secondary outcome measures (1)
- Immunohistochemistry for other markers [Time frame: 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.]
Eligibility criteria
Inclusion criteria
- Clinically diagnosis of breast cancer (by FNAC or Biopsy)
- Not received any chemotherapy or surgical intervention except core biopsy.
- Planed for Breast cancer surgery
- Willing to give consent for the study
Exclusion criteria
- Clinically diagnosis of Metastatic breast cancer
- Received any anticancer therapy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
India · 1 center
- Tata Memorial Center — Mumbai
Publications
- 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. PMID 23222717
- Hockel M, Vaupel P. Biological consequences of tumor hypoxia. Semin Oncol. 2001 Apr;28(2 Suppl 8):36-41. PMID 11395851
- 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. PMID 23915189
- 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. PMID 41934415
Identifiers
NCT: NCT03797482 · Protocol 254