Breast Cancer FemaleHypoxiaNCT03797482
A Prospective Evaluation of the Peri-operative Hypoxia in Breast Cancer
An observational study of Breast Cancer Female, run by Tata Memorial Hospital at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- Intra-operative Tumor Tissue Biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteIndia
- Study dates
- 27 Nov 2017to 30 Dec 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women diagnosed with breast cancer at outpatient clinic
Who may be able to join
- 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
Who cannot join
- Clinically diagnosis of Metastatic breast cancer
- Received any anticancer therapy
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Breast Cancer Female
- Being tested
- Intra-operative Tumor Tissue Biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-operative Tumor Tissue BiopsyProcedure or surgery
Also called Breast cancer surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Intra-operative tumour tissue biopsies | Intra-operative tumour tissue biopsies will be collected for all patients Receives: Procedure: Intra-operative Tumor Tissue Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2019
- Study start27 Nov 2017
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tata Memorial Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr Rajendra A. Badwe, Tata Memorial Centre
- Investigators
- Rajendra Badwe, Principal investigator, Director, tata Memorial Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03797482
- Sponsor's protocol ID
- Protocol 254
- Acronym
- Hypoxia
- Status last verified
- Sep 2026
- First submitted
- 28 Jun 2018
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 23222717Hockel M, Vaupel P. Biological consequences of tumor hypoxia. Semin Oncol. 2001 Apr;28(2 Suppl 8):36-41.
PubMed 11395851Hoesel 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.
PubMed 23915189Gardi N, Chaubal R, Gandhi KA, Kadam A, Singh A, Raja AS, Vanmali V, Hawaldar R, Sale S, Joshi S, Badwe R, Gupta S. Clinically actionable alterations in Indian breast cancer patients derived through whole transcriptome sequencing. Indian J Med Res. 2026 Jan;163(1):95-103. doi: 10.25259/IJMR_1642_2024.
PubMed 41934415