A Trial intended to study the role of sentinel node biopsy technique in women with breast cancer who have had prior surgery for a breast lump
Not Applicable
Completed
- Conditions
- Health Condition 1: null- Breast cancer patients-post lumpectomy
- Registration Number
- CTRI/2014/08/004920
- Lead Sponsor
- Regional Cancer Centre Trivandrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
1)pT1,T2 tumours (based on the pathology report)
2)N0 breast cancers(clinically and radiologically)
3)Invasive breast adenocarcinoma
Exclusion Criteria
1)Prior axillary surgery/Non oncologic breast surgery/ biopsies other than excision or lumpectomy/surgery to the ipsilateral breast prior to 3 months
2)Prior irradiation to the breast or axilla
3)Performance status ECOG 3,4
4)Pregnant and lactating women
5)Neoadjuvant Chemotherapy
6)Known Allergy to Human serum Albumin , Isosulfan Blue
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To validate the efficacy of the sentinel node biopsy technique in post lumpectomy breast cancer patients in terms of <br/ ><br>Identification rate <br/ ><br>False negative rateTimepoint: To validate the efficacy of the sentinel node biopsy technique in post lumpectomy breast cancer patients in terms of <br/ ><br>Identification rate <br/ ><br>False negative rate
- Secondary Outcome Measures
Name Time Method To determine sensitivity ,specificity ,positive and negative predictive value of the technique by comparison to axillary dissectionTimepoint: 2 years