Clinical trial · Interventional
Immun Checkpoint Washout in Patients With Invasive Ductal Breast Cancer
Detection of Lymph Node Positivity in Patients With Invasive Ductal Breast Cancer Using Immun Checkpoint Washout
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Metastatic | Breast Neoplasm | PROBABILISTIC | 0.70 |
| Breast Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Benign Lymph Node Washout | Diagnostic Test | — | UNRESOLVED |
| Malign Lymph Node Washout | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Metastatic axillary lymph nodes suspected
- interventionNames
- Diagnostic Test: Malign Lymph Node Washout
- type
- OTHER
- label
- Benign lymph nodes
- interventionNames
- Diagnostic Test: Benign Lymph Node Washout
Primary outcomes (1)
- measure
- The immune checkpoints in lymph node washout fluid
- timeFrame
- 3 monthts
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (3)
- RESULTGiuliano 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
- RESULTMoon 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
- RESULTSallout 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