Immune checkpoint washout for axillary lymph node staging in invasive ductal breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Patients with histopathologically confirmed invasive ductal carcinoma who are planned for neoadjuvant therapy will have washout fluid collected from axillary lymph nodes characterized as benign or suspicious on ultrasound. Washout specimens will be analyzed for immune checkpoint markers and compared with results from fine-needle aspiration or core biopsy and final pathology. The aim is to determine whether immune checkpoint washout could serve as a faster, lower-cost adjunct to ultrasound and biopsy for lymph node staging. Standard exclusions include negative FNAB of a suspected metastatic node, malignant FNAB of a presumed healthy node, pregnancy, immunodeficiency, or another primary malignancy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histopathologically proven invasive ductal carcinoma
* Patients who will have neoadjuvant therapy

Exclusion Criteria:

* The fine-needle aspiration biopsy (FNAB) result of the suspected metastatic lymph node is negative.
* The FNAB result of the presumed healthy lymph node is malignant.
* They refuse to participate in the study.
* They have another primary malignancy.
* They are pregnant.
* They have a history of immunodeficiency.

Where it's running

• Istanbul Training and Research Hospital
  Istanbul, Turkey (Türkiye) Recruiting

Study contacts

• Study coordinator: Ufuk Oguz Idiz, Assoc. Prof. MD. PhD
• Email: ufukidiz@gmail.com
• Phone: +905062044714

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.