Clinical trial NCT03797482: A Prospective Evaluation of the Peri-operative Hypoxia in Breast Cancer
Official title: A Prospective Evaluation of the Peri-operative Hypoxia in Breast Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer Female
Lead sponsor: Tata Memorial Hospital
Sponsor class: OTHER_GOV
First posted: 2019-01-09
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women diagnosed with breast cancer at outpatient clinic

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Gene expression changes
timeFrame: 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:
measure: Immunohistochemistry for other markers
timeFrame: 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.
Other outcomes:
Locations:
city: Mumbai
country: India
facility: Tata Memorial Center
state: Maharashtra
Study officials:
affiliation: Director, tata Memorial Centre
name: Rajendra Badwe
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: Hockel M, Vaupel P. Biological consequences of tumor hypoxia. Semin Oncol. 2001 Apr;28(2 Suppl 8):36-41.
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.