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

Tata Memorial Hospital

Status: Enrolling

Conditions: Breast Cancer Female

Treatments: Procedure: Intra-operative Tumor Tissue Biopsy

Study type: Observational

Funder types: Other

Identifiers

NCT03797482

Protocol 254

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

500 participants in 1 patient group

Intra-operative tumour tissue biopsies

Description:

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

Treatment:

Procedure: Intra-operative Tumor Tissue Biopsy