Cancer-stromal cell interactions mediated by hypoxia-inducible factors promote angiogenesis, lymphangiogenesis, and metastasis.
G L Semenza
https://pubmed.ncbi.nlm.nih.gov/23222717Actively Recruiting
Age: 18Years +
FEMALE
ID03797482
A Prospective Evaluation of the Peri-operative Hypoxia in Breast Cancer
Led by Tata Memorial Hospital · Updated on 2025-09-10
500
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to understand the effects of acute hypoxia that occurs during breast cancer surgery. Researchers will study changes in the tumor caused by oxygen deprivation during the operation by collecting tumor tissue samples at different times during surgery. The study focuses specifically on how gene expression in the tumor changes during the surgical process, which lasts about 30 to 90 minutes on average. During surgery, three tumor samples will be taken while the patient is under anesthesia: one before surgery starts, one midway when half the tumor has been devascularized, and one after the tumor is fully removed. These samples will be preserved using methods like snap freezing, RNA later storage, and paraffin sections for future genomic and protein studies. Participants will have tumor tissue biopsies collected only during surgery without any additional clinical follow-up after sampling. Researchers will evaluate gene expression changes and use immunohistochemistry to study other markers in the tumor tissue. The entire process occurs during the surgical procedure without extended monitoring or post-surgery data collection.
CONDITIONS
Brief Title
A Prospective Evaluation of the Peri-operative Hypoxia in Breast Cancer
Who Can Participate
Age: 18Years +
FEMALE
Eligibility Criteria
You may qualify if you...
- Clinically diagnosed with breast cancer by FNAC or biopsy
- No prior chemotherapy or surgical treatment except core biopsy
- Scheduled for breast cancer surgery
- Willing to provide consent for participation
You will not qualify if you...
- Diagnosed with metastatic breast cancer
- Have received any anticancer therapy before the study
AI-Screening
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Complete this quick 3-step screening to check your eligibility
1
2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Surgery and Immediate Post-operative Care
Duration - 30 to 90 minutes
Participants undergo breast cancer surgery during which three tumor tissue biopsies are collected: one prior to starting surgery, one midway through surgery, and one after tumor excision. These samples are stored for future genomic and proteomic analysis.
1 surgical procedure visit (in-person)
Trial Site Locations
Total: 1 location
1
Tata Memorial Center
Mumbai, Maharashtra, India, 400012
Actively Recruiting
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Research Team
S
Shalaka Joshi, MS, MCh
R
Rohini A Hawaldar
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
Biological consequences of tumor hypoxia.
M Höckel, P Vaupel
https://pubmed.ncbi.nlm.nih.gov/11395851The complexity of NF-κB signaling in inflammation and cancer.
Bastian Hoesel, Johannes A Schmid
https://pubmed.ncbi.nlm.nih.gov/23915189Clinically actionable alterations in Indian breast cancer patients derived through whole transcriptome sequencing.
Nilesh Gardi, Rohan Chaubal, Khushboo A Gandhi...
https://pubmed.ncbi.nlm.nih.gov/41934415