NCT03797482

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Tata Memorial Hospital · Other Government
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer Female

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-11-27
• Primary completion: 2025-09-30
• Completion: 2025-11-30
• First posted: 2019-01-09
• Last updated: 2025-09-10

Locations

1 site across 1 country: India