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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

Validation of sentinel lymph node biopsy technique after prior lumpectomy in early breast cancer patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/08/004920
Enrollment
40
Registered
2014-08-25
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Breast cancer patients-post lumpectomy

Interventions

Intervention1: Sentinel lymph node biopsy: sentinel lymph node biopsy in post lumpectomy early breast cancer patients Control Intervention1: Literature data of sentinel lymph node biopsy technique i

Sponsors

Regional Cancer Centre Trivandrum
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)pT1,T2 tumours (based on the pathology report) 2)N0 breast cancers(clinically and radiologically) 3)Invasive breast adenocarcinoma

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
To validate the efficacy of the sentinel node biopsy technique in post lumpectomy breast cancer patients in terms of Identification rate False negative rateTimepoint: 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

MeasureTime frame
To determine sensitivity ,specificity ,positive and negative predictive value of the technique by comparison to axillary dissectionTimepoint: 2 years—

Countries

India

Contacts

Public ContactPaul Augustine

Regional cancer centre

dasusridhar@gmail.com9567170760

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026