Incidence of tumour cells in lymphatics as effect of breast conservation surgery for breast cancer patinets

Randomized Controlled Trial to Evaluate the Role of Iatrogenic Displacement of Tumor cells to Axillary Lymph Nodes.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/11/010589

Enrollment

700

Registered

2017-11-22

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- Operable Breast Cancer Female patient

Interventions

Intervention1: Axilla First appproach arm: Patient in the axilla first approach arm will undergo an axillary sampling and clearance first followed by a wide local excision for the primary breast tumor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Female patient with breast cancer age 18 years and above 2.T1 N0 / T2 N0 tumours 3.Patient undergoing upfront breast conserving surgery 4.Willing to give consent to participate in the study

Exclusion criteria

Exclusion criteria: 1.Previous h/o lumpectomy or incision biopsy 2.Patient planned for Neoadjuvant Chemotherapy 3.Locally advanced or metastatic breast tumours 4.Lactating patients

Design outcomes

Primary

Measure	Time frame
To study the incidence of Iatrogenic Displacement of Tumor Cells in afferent lymphatics as a consequence of tumor handlingTimepoint: 30 days after surgery	—

Secondary

Measure	Time frame
1.To study the incidence of micrometastases in afferent lymphatics as a consequence of tumor handling Timepoint: From the day of surgery to post operative Day 15;2.To study the impact of ITCs on disease free survivalTimepoint: 5 years	—

Countries

India

Contacts

Public ContactDr Mihir Chandarana

Tata Memorial Hospital

drmihirchandarana@gmail.com9619576963

Outcome results

None listed

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