Immun Checkpoint Washout in Patients With Invasive Ductal Breast Cancer

NCT07003009 | Recruiting

• 1 other identifier: Breast lymph node
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Invasive ductal carcinoma is the most common type of invasive breast cancer. In cases where axillary lymph node metastases are diagnosed through screening, they can be found in up to 25% of cases, and in symptomatic cases, up to 60% of cases. The clinical detection accuracy of axillary lymph node metastases is only 33%. Accurate staging of lymph nodes in breast cancer patients is crucial for both prognosis and treatment. Ultrasonography is much more sensitive than physical examination alone for determining axillary lymph node involvement in breast cancer staging. Fine needle aspiration biopsy or core biopsy is diagnostic in lymph nodes that cannot be clarified solely by ultrasonography or are suspicious. Although biopsy sampling yields high diagnostic rates, it requires an experienced pathologist and sometimes takes weeks to yield results. Therefore, there is a need for faster and less costly diagnostic methods for diagnosing axillary metastases. Among thyroid cancers, papillary thyroid carcinomas, a malignancy in which the lymph node washout method is used to determine lymph node metastasis, are the most common. In papillary thyroid cancer patients, washout sampling of neck lymph nodes by fine needle aspiration, searching for thyroglobulin, a protein normally found in thyroid tissue, is considered one of the most valid methods for detecting lymph node metastasis in this cancer. In recent years, immune checkpoint molecules associated with cancer have been widely used as biomarkers and agents in both diagnosis and treatment for cancer patients. There are numerous publications in the literature regarding the expression of immune checkpoint molecules such as Programmed cell death protein 1 (PD-1), Programmed death ligand 1 (PD-L1), and The cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) on the cell surface of breast cancer patients. Although the natural soluble forms of receptors and ligands of immune checkpoint molecules exist and they are important components of immune regulation, their exact mechanisms of action have not yet been determined. There are five studies in the literature evaluating the status of soluble immune checkpoint molecules in breast cancer patients, with one being a review article. It is highly likely that immune checkpoint molecules found on both the cell surface and soluble in blood and body fluids are also present in tumor metastatic regions. There is no study using these immunological biomarkers to determine metastasis in invasive ductal carcinoma patients with metastatic axillary lymph nodes ın the literature. In this study, the investigators will evaluate the soluble levels of immune checkpoint molecules in washout fluids obtained from metastatic axillary lymph nodes and benign lymph nodes in patients with invasive ductal breast carcinoma, and will assess the effectiveness of these immune checkpoint molecules and the washout method in diagnosing metastasis.

Conditions

Breast Cancer Metastatic; Breast Carcinoma

Keywords

Immune checkpoints; Breast Cancer; Lymph node; Washout

Outcome Measures

Primary Outcomes (1)

• The immune checkpoints in lymph node washout fluid

  The immune checkpoints (sCD25 (IL-2Ra), 4-1BB, B7.2 (CD86), Free Active Transforming growth factor (TGF)-β1, The cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), Programmed death ligand 1 (PD-L1), Programmed cell death protein 1 (PD-1), T-cell immunoglobulin and mucin domain 3 (Tim-3), Lymphocyte-activation gene 3 (LAG-3), and Galectin-9) will be measured at lymph node washout fluid and the results will be presented in pg/ml.

  3 monthts

Secondary Outcomes (1)

• The immune checkpoints in blood

  3 monthts

Study Arms (2)

Metastatic axillary lymph nodes suspected

EXPERIMENTAL

Diagnostic Test: Malign Lymph Node Washout

Benign lymph nodes

OTHER

Diagnostic Test: Benign Lymph Node Washout

Interventions

Malign Lymph Node Washout DIAGNOSTIC_TEST

During routine axillary lymph node sampling, which is performed as part of standard staging using imaging methods, a washout sample (which is not not routinely applied ) will be obtained by injecting 1 cc of 0.9% saline into axillary lymph nodes suspected to be metastatic. The aspirated washout sample will be placed in a biochemistry gel tube labeled as Sample 1.

Also known as: Fine needle aspiration biopsy, Washout

Metastatic axillary lymph nodes suspected

Benign Lymph Node Washout DIAGNOSTIC_TEST

Description: During the biopsy performed to histopathologically confirm the benign nature of a radiologically presumed benign axillary lymph node, a washout sampling will also be conducted by injecting 1 cc of 0.9% saline into benign lymph node. The aspirated washout sample will be placed in a biochemistry gel tube labeled as Sample 2.

Also known as: Fine needle aspiration biopsy, Washout

Benign lymph nodes

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Breast Cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul Training and Research Hospital: lead

Study Sites (1)

Istanbul Training and Research Hospital

Istanbul, 34098, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• Giuliano AE, Connolly JL, Edge SB, Mittendorf EA, Rugo HS, Solin LJ, Weaver DL, Winchester DJ, Hortobagyi GN. Breast Cancer-Major changes in the American Joint Committee on Cancer eighth edition cancer staging manual. CA Cancer J Clin. 2017 Jul 8;67(4):290-303. doi: 10.3322/caac.21393. Epub 2017 Mar 14.

  PMID: 28294295 BACKGROUND

• Moon JH, Kim YI, Lim JA, Choi HS, Cho SW, Kim KW, Park HJ, Paeng JC, Park YJ, Yi KH, Park DJ, Kim SE, Chung JK. Thyroglobulin in washout fluid from lymph node fine-needle aspiration biopsy in papillary thyroid cancer: large-scale validation of the cutoff value to determine malignancy and evaluation of discrepant results. J Clin Endocrinol Metab. 2013 Mar;98(3):1061-8. doi: 10.1210/jc.2012-3291. Epub 2013 Feb 7.

  PMID: 23393171 BACKGROUND

• Sallout L, Tashkandi M, Moqnas A, AlMajed H, Al-Naeem A, Alwelaie Y. Fine-needle aspiration biopsy of axillary lymph nodes: A reliable diagnostic tool for breast cancer staging. Cancer Cytopathol. 2024 Feb;132(2):103-108. doi: 10.1002/cncy.22770. Epub 2023 Oct 16.

  PMID: 37843531 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Biopsy, Fine-Needle

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Punctures; Investigative Techniques

Central Study Contacts

Ufuk Oguz Idiz, Assoc. Prof. MD. PhD

CONTACT

+905062044714; ufukidiz@gmail.com

Mert Ali Dolek, MD

CONTACT

+905364310364; mertdolek@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of General Surgery, Principal Investigator, Clinical Associate professor

Model Details: A washout sample will be obtained by axillary lymph nodes suspected to be metastatic which is not performed in routine lymph node biopsy procedure. Similarly, an axillary lymph node that is deemed non-metastatic based on imaging findings will be sampled under ultrasound guidance for the same patients.

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: June 4, 2025
• Study Start: January 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: October 1, 2025
• Last Updated: June 4, 2025

Record last verified: 2025-05

Locations

TU (1)