A Prospective Evaluation of the Peri-operative Hypoxia in Breast Cancer
NCT ID: NCT03797482
Last Updated: 2025-09-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
500 participants
OBSERVATIONAL
2017-11-27
2025-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Intra-operative tumour tissue biopsies
Intra-operative tumour tissue biopsies will be collected for all patients
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Not received any chemotherapy or surgical intervention except core biopsy.
3. Planed for Breast cancer surgery
4. Willing to give consent for the study
Exclusion Criteria
2. Received any anticancer therapy
18 Years
FEMALE
No
Sponsors
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Tata Memorial Hospital
OTHER_GOV
Responsible Party
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Dr Rajendra A. Badwe
Director, Tata Memorial Centre and Professor, Department of Surgical Oncology
Principal Investigators
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Rajendra Badwe
Role: PRINCIPAL_INVESTIGATOR
Director, tata Memorial Centre
Locations
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Tata Memorial Center
Mumbai, Maharashtra, India
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Hockel M, Vaupel P. Biological consequences of tumor hypoxia. Semin Oncol. 2001 Apr;28(2 Suppl 8):36-41.
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.
Other Identifiers
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Protocol 254
Identifier Type: -
Identifier Source: org_study_id
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