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Construction of Microfluidic Exosome Chip for Diagnosis of Lung Metastasis of Osteosarcoma

2022年11月14日 更新者:Ruijin Hospital

Construction and Clinical Application of Microfluidic Exosome Chip for Early Diagnosis of Pulmonary Metastasis of Osteosarcoma

Use exosome microfluidic chips to establish a combination of exosome subgroup level (exosome barcode) markers for the early diagnosis of osteosarcoma lung recurrence, and establish the basis of microfluidic chip based exosome biomarker for monitoring the early therapeutic response of the second-line therapy for recurrent osteosarcoma.

研究概览

地位

完全的

详细说明

Osteosarcoma is the most common primary malignant bone tumor in adolescents, and lung metastasis is the main cause of its poor prognosis. Our previous data on the basis of second-line chemotherapy combined with VEGFRi targeted therapy for patients with lung metastases from osteosarcoma showed that some patients with early diagnosis of lung metastases may achieved long-term tumor-free survival upon prompt treatment. However, plasma biomarker for the early detection of recurrent osteosarcoma is still lacking to date. Our preliminary studies indicate that exosome is a potential source of liquid biomarker for the early diagnosis of osteosarcoma lung metastasis. We, therefore, have developed a microfluidic biochip based on nano-zinc oxide microcolumns. This chip can quickly and efficiently screen and capture exosomes and achieve quantitative and qualitative detection of exosome and its subgroups. This technology may be able to achieve early sensitive exosome quantification for lung metastasis of osteosarcoma. But the clinical efficacy and utility of the microfluidic chip based exosome detection for the early diagnosis osteosarcoma recurrence remains to be validated.

This research plan uses our newly developed microfluidic chip technology to capture and efficiently capture exosomes for quantitative and qualitative and marker screening, and establish a combination of exosome subgroups level as a biomarker for the early diagnosis of osteosarcoma lung metastasis.

研究类型

观察性的

注册 (实际的)

60

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Shanghai
      • Shanghai、Shanghai、中国、200025
        • Ruijin Hospital Shanghai Jiao Tong University School of Medicine

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

12年 至 60年 (孩子、成人)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

  1. Surgical specimens and peripheral blood specimens of previous patients with osteosarcoma in the specimen bank,
  2. Patients who were diagnosed with osteosarcoma and were hospitalized in the Department of Orthopedics of Ruijin Hospital

描述

Inclusion Criteria:

  1. Biopsy pathologically diagnosed as primary high-grade osteosarcoma (including ordinary osteosarcoma, vasodilatory osteosarcoma, small cell osteosarcoma, high-grade surface osteosarcoma);
  2. Age no less than 12 years old and no older than 60 years old;
  3. New-onset patients who have not received chemotherapy, radiotherapy, surgery, Chinese medicine and other treatments.
  4. The primary site is the limbs and pelvis.

Exclusion Criteria:

  1. Pathological diagnosis of surgical gross specimens except primary high-grade osteosarcoma;
  2. Failure to collect circulating exosomes as planned;
  3. Suffering from chronic diseases, which may lead to an increase in non-tumor-related circulating exosomes, such as autoimmune diseases , Chronic infections, etc.;
  4. The use of targeted drugs may lead to a decrease in tumor-related circulating exosomes;
  5. Withdrawal from the trial for any reason.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
The association of disease recurrence with plasma levels of exosome and its subgroups.
大体时间:through study completion, an average of 2 years
After the patients were enrolled, MRI of the primary surgical site (enhanced if necessary), chest CT and bone scan were performed for the surveillance of disease recurrence according to the National Comprehensive Cancer Network (NCCN) guideline. The number of total plasma exosome as well as its subgroups (Vim, cluster of differentiation 44 (CD44), Integrins positive, etc.) were measured based on the microfluidic chip. The association of sarcoma recurrence with plasma exosome levels was then determined to validate the clinical efficacy of plasma exosome as a potential liquid biomarker.
through study completion, an average of 2 years

次要结果测量

结果测量
措施说明
大体时间
The change of plasma exosome level during the postoperative surveillance from baseline
大体时间:through study completion, an average of 2 years
The exosome and its subgroup levels were measured on the individual basis in comparison to the baseline to study the dynamic change of exosome during the postoperative surveillance from baseline.
through study completion, an average of 2 years
The correlation of the therapeutic response with plasma levels of exosome and its subgroups.
大体时间:at 1 month post-therapy
For patients with recurrent disease who start second- or third- line therapy, the number of total plasma exosome as well as its subgroups (Vim, cluster of differentiation 44 (CD44), Integrins positive, etc.) were measured at 1 month post-therapy. We then assess the association of the exosome biomarker with the treatment response, as determined by Response Evaluation Criteria In Solid Tumours (RECIST) 1.1.
at 1 month post-therapy
The correlation of microfluidic chip based exosome quantification with conventional approach
大体时间:through study completion, an average of 2 years
We investigate the correlation of microfluidic chip based plasma exosome levels with the conventional methodologies, such as Nanoparticle tracking analysis (NTA) and Western-blot
through study completion, an average of 2 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2020年10月1日

初级完成 (实际的)

2022年9月30日

研究完成 (实际的)

2022年9月30日

研究注册日期

首次提交

2021年10月7日

首先提交符合 QC 标准的

2021年10月24日

首次发布 (实际的)

2021年11月1日

研究记录更新

最后更新发布 (实际的)

2022年11月15日

上次提交的符合 QC 标准的更新

2022年11月14日

最后验证

2022年10月1日

更多信息

与本研究相关的术语

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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