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NCT Number: NCT03797482

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

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.

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Key information

Conditions

Breast Cancer Female

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

About this study

Three tumor samples will be obtained after the patient is under anaesthesia,

  • Prior to starting surgery (Sample A)
  • 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)
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intra-operative Tumor Tissue Biopsy

Procedure

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 names: Breast cancer surgery

Primary outcomes

  1. 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.

    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 outcomes

  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.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Rohini A Hawaldar

CONTACT

[email protected]

09820432613

Shalaka Joshi, MS, MCh

CONTACT

[email protected]

9869089803 ext. 4265

Sponsors and collaborators

Lead sponsor

Tata Memorial Hospital

Other Gov

Registry information

Acronym: Hypoxia

Important dates

Study start
2017
Primary completion
2025
Study completion
2025
First posted
Jan 9, 2019
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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