NCT03797482

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 27, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2018

Completed
7 months until next milestone

First Posted

Study publicly available on registry

January 9, 2019

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
Last Updated

September 10, 2025

Status Verified

April 1, 2025

Enrollment Period

7.8 years

First QC Date

June 28, 2018

Last Update Submit

September 3, 2025

Conditions

Breast Cancer Female

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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.

Study Arms (1)

Intra-operative tumour tissue biopsies

Intra-operative tumour tissue biopsies will be collected for all patients

Procedure: Intra-operative Tumor Tissue Biopsy

Interventions

Intra-operative Tumor Tissue BiopsyPROCEDURE

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.

Also known as: Breast cancer surgery
Intra-operative tumour tissue biopsies

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen diagnosed with breast cancer, undergoing surgery upfront
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women diagnosed with breast cancer at outpatient clinic

You may qualify if:

  • 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

You may not qualify if:

  • Clinically diagnosis of Metastatic breast cancer
  • Received any anticancer therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tata Memorial Center

Mumbai, Maharashtra, 400012, India

RECRUITING

Related Publications (3)

  • 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.

    PMID: 23222717BACKGROUND

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

    PMID: 11395851BACKGROUND

  • 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.

    PMID: 23915189BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Breast cancer tumor tissue

Study Officials

  • Rajendra Badwe

    Director, tata Memorial Centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shalaka Joshi, MS, MCh

CONTACT

9869089803drjoshishalaka@gmail.com

Rohini A Hawaldar

CONTACT

09820432613rwhawaldar@gmail.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Tata Memorial Centre and Professor, Department of Surgical Oncology

Study Record Dates

First Submitted

June 28, 2018

First Posted

January 9, 2019

Study Start

November 27, 2017

Primary Completion

September 30, 2025

Study Completion

November 30, 2025

Last Updated

September 10, 2025

Record last verified: 2025-04

Locations

IN(1)