跳至主要内容
临床试验/NCT07003009
NCT07003009招募中不适用

Detection of Lymph Node Positivity in Patients With Invasive Ductal Breast Cancer Using Immun Checkpoint Washout

Istanbul Training and Research Hospital2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年1月1日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
2
主要终点
The immune checkpoints in lymph node washout fluid

研究概览

简要总结

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.

详细描述

The most common cancer in women worldwide and the leading cause of death among those aged 20-59 is breast cancer. Invasive breast cancers are primarily classified as ductal and lobular. However, special types of invasive breast cancers, which constitute 10% of total cases, have been included in the current histological classification.

Invasive ductal carcinoma is the most frequently observed type among invasive breast cancers (80%) and is also defined as invasive ductal carcinoma of no special type. Macroscopic or microscopic axillary lymph node metastases have been detected in up to 25% of screening-diagnosed cases and up to 60% of symptomatic cases of invasive ductal carcinoma.

The clinical staging of breast cancer is primarily determined by the physical examination of the breast skin, breast tissue, and regional lymph nodes (axillary, supraclavicular, and internal mammary). However, the accuracy of clinically determining axillary lymph node metastases is only 33%. Proper lymph node staging in breast cancer patients is crucial for both prognosis and treatment.

Ultrasound is significantly more sensitive than physical examination alone in determining axillary lymph node involvement in breast cancer staging. For lymph nodes that remain indeterminate or suspicious on ultrasound, fine-needle aspiration biopsy or core biopsy provides a definitive diagnosis. The most commonly used staging system is the TNM staging system. The American Joint Committee on Cancer (AJCC) recently modified the TNM system. According to the latest TNM staging, the presence of macrometastases in ipsilateral level 1 and level 2 axillary lymph nodes classifies breast cancer as stage 2A or higher. Although biopsy sampling has a high diagnostic accuracy, it requires experienced pathologists, and the evaluation process can take weeks. Therefore, there is a need for faster and more cost-effective diagnostic methods for detecting axillary metastases.

The lymph node washout technique is used to determine lymph node metastasis in malignancies such as papillary thyroid carcinoma, the most common type of thyroid cancer. Papillary thyroid carcinomas generally do not exhibit aggressive clinical behavior and have favorable long-term prognoses. However, at the time of diagnosis, cervical and mediastinal lymph node involvement ranges from 27% to 46%, and the postoperative recurrence rate is between 3% and 30%. Thus, determining preoperative lymph node involvement and distinguishing it from benign reactive lymphadenitis is essential. For this purpose, fine-needle aspiration with thyroglobulin washout sampling has recently become widely used worldwide. In patients with papillary thyroid carcinoma, fine-needle aspiration of cervical lymph nodes and testing for thyroglobulin, a protein normally present in thyroid tissue, is considered one of the most reliable methods for detecting lymph node metastasis. A large-scale study by Moon et al. found that fine-needle aspiration thyroglobulin washout had a sensitivity of 93.2% and a specificity of 95.9% in detecting lymph node metastases in papillary thyroid carcinoma.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 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.

结局指标

主要结局

The immune checkpoints in lymph node washout fluid

时间窗: 3 monthts

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.

次要结局

  • The immune checkpoints in blood(3 monthts)

研究者

发起方
Istanbul Training and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Ufuk Oguz Idiz

Chief of General Surgery, Principal Investigator, Clinical Associate professor

Istanbul Training and Research Hospital

研究点 (2)

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