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

Breast Cancer Female Clinical Trial

— Hypoxia  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03797482
• Other study ID #: Protocol 254
• Status: Recruiting
• Start date: November 27, 2017
• Est. completion date: November 30, 2025

Study information

• Verified date: April 2023
• Source: Tata Memorial Hospital
• Contact: Shalaka Joshi, MS, MCh
• Phone: 9869089803
• Email: drjoshishalaka[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: November 30, 2025
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms
• Hypoxia

Intervention

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.

Locations

Country	Name	City	State
India	Tata Memorial Center	Mumbai	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Tata Memorial Hospital

Country where clinical trial is conducted

India, 

References & Publications (3)

Hockel M, Vaupel P. Biological consequences of tumor hypoxia. Semin Oncol. 2001 Apr;28(2 Suppl 8):36-41. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gene expression changes	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).	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.
Secondary	Immunohistochemistry for other markers	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.	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.