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Association of suspicious axillary node and sentinel node in breast cancer to minimizing axillary surgery, prospective cohort study

Association of suspicious axillary node and sentinel node in breast cancer to minimizing axillary surgery, prospective cohort study

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20230725004
Enrollment
40
Registered
2023-07-25
Start date
2021-01-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Breast cancer, early breast cancer, locally advance breast cancer Breast cancer, Sentinel lymph node biopsy, Targeted axillary dissection, Axillary lymph node dissection

Interventions

Patients underwent routine mammograms and ultrasound of the breast and axillary lymph nodes performed by a breast radiologist. If a suspicious node was identified, FNA or core needle biopsy was perfor
Experimental Procedure/Surgery
Fine needle aspiration and clip insertion into the suspicious axillary lymph node

Sponsors

Ramathibodi hospital Mahidol University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: all women aged more than 18 years with pathologically confirmed invasive breast cancer with early stage cT1-2N0-1 M0 and suspicious nodes detected by ultrasonography or mammography with surgery upfront or breast cancer stage cT1-4N2M0, cT3-4N1M0, or cT1-2N0-1M0 who received neoadjuvant systemic treatment with suspicious nodes detected by ultrasonography or mammography and underwent surgery in the Breast and Endocrine Unit, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Thailand, between January 2021 and December 2022

Exclusion criteria

Exclusion criteria: prior cancer, ineligibility for FNA or CNB of the axilla, or allergies to nickel or titanium

Design outcomes

Primary

MeasureTime frame
whether a suspicious node was a sentinel node by correlating the suspected axillary lymph nodes at 2 months after end of the intervention Intra operative finding of clip suspicious node in sentinel node (Number, percent)

Secondary

MeasureTime frame
accuracy of FNA of suspicious nodes at 2 months after end of the intervention Compare number of intra operative finding of clip suspicious node in sentinel node (Number, percent),Loss clip at 2 months after end of the intervention Number of operation that cannot identified clip in specimen (Number, percent)

Countries

Thailand

Contacts

Public ContactLakkana Adieklarpwong

Faculty of Medicine Ramathibodi Hospital

lakkana.adi@mahidol.ac.th6622011315

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026