A Prospective Evaluation of the Peri-operative Hypoxia in Breast Cancer

Recruiting

• Conditions: Breast Cancer Female
• Interventions: Procedure: Intra-operative Tumor Tissue Biopsy

• Registration Number: NCT03797482
• Lead Sponsor: Tata Memorial Hospital

Brief Summary

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.

Study Timeline

• Study Start: 2017-11-27
• Study First Submitted: 2018-06-28
• Study First Submitted QC: 2019-01-04
• Study First Posted: 2019-01-09
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-08
• Last Update Posted: 2025-04-09
• Primary Completion: 2025-07-30
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 500

Inclusion Criteria

1. Clinically diagnosis of breast cancer (by FNAC or Biopsy)
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

1. Clinically diagnosis of Metastatic breast cancer
2. Received any anticancer therapy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intra-operative tumour tissue biopsies	Intra-operative Tumor Tissue Biopsy	Intra-operative tumour tissue biopsies will be collected for all patients

Primary Outcome Measures

Name	Time	Method
Gene expression changes	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.	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).

Secondary Outcome Measures

Name	Time	Method
Immunohistochemistry for other markers	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.	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.

Trial Locations

Locations (1)

Tata Memorial Center; 🇮🇳 Mumbai, Maharashtra, India