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

Completed

• Conditions: Breast cancer patients-post lumpectomy

• Registration Number: CTRI/2014/08/004920
• Lead Sponsor: Regional Cancer Centre Trivandrum

Brief Summary

This is a single institutional , single arm , interventional study being conducted to test the efficacy of the sentinel lymph node biopsy technique in post lumpectomy  early breast cancer patients.The total number of patients will be 40 with the  duration being 2 years.The primary end point of the study will be sentinel node identification rate and false negative rate.The results will be compared with similar studies conducted in the  primary setting. Our ultimate aim is to use sentinel node biopsy technique as a staging tool for the axilla and eventually avoid the morbidity of axillary dissection  in this group of patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04-30
• Last Update Posted: 2016-04-05

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• 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
Identification rate	To validate the efficacy of the sentinel node biopsy technique in post lumpectomy breast cancer patients in terms of | Identification rate | False negative rate
False negative rate	To validate the efficacy of the sentinel node biopsy technique in post lumpectomy breast cancer patients in terms of | Identification rate | False negative rate
To validate the efficacy of the sentinel node biopsy technique in post lumpectomy breast cancer patients in terms of	To validate the efficacy of the sentinel node biopsy technique in post lumpectomy breast cancer patients in terms of | Identification rate | 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 dissection	2 years

Trial Locations

Locations (1)

Regional cancer center; 🇮🇳 Thiruvananthapuram, KERALA, India

Regional cancer center

🇮🇳Thiruvananthapuram, KERALA, India

Paul Augustine

Principal investigator

04712443290

augustpaul@gmail.com