Evaluating the effects of hypoxia during breast cancer surgery
A Prospective Evaluation of the Peri-operative Hypoxia in Breast Cancer
Tata Memorial Hospital · NCT03797482
This study is testing how low oxygen levels during breast cancer surgery affect the tumor and treatment results by collecting samples at different stages of the procedure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Tata Memorial Hospital (other gov) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Mumbai, Maharashtra) |
| Trial ID | NCT03797482 on ClinicalTrials.gov |
What this trial studies
This study aims to investigate the impact of acute hypoxia that occurs during surgery on breast cancer patients. It involves collecting three tumor samples at different stages of the surgical procedure: before surgery, midway through when the tumor is partially devascularized, and after excision. These samples will be preserved for future genomic and proteomic analysis to better understand the biological effects of hypoxia on tumor behavior and treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates are female patients diagnosed with breast cancer who are scheduled for surgery and have not received prior chemotherapy or surgical intervention.
Not a fit: Patients with metastatic breast cancer or those who have undergone any anticancer therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this research could lead to improved surgical strategies and treatment protocols for breast cancer patients.
How similar studies have performed: While the specific approach of evaluating intra-operative hypoxia in breast cancer is relatively novel, similar studies in other cancer types have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Mumbai, Maharashtra
- Tata Memorial Center — Mumbai, Maharashtra, India (RECRUITING)
Study contacts
- Principal investigator: Rajendra Badwe — Director, tata Memorial Centre
- Study coordinator: Shalaka Joshi, MS, MCh
- Email: drjoshishalaka@gmail.com
- Phone: 9869089803
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer Female