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临床试验/NCT05101655
NCT05101655已完成不适用

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

Ruijin Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
The association of disease recurrence with plasma levels of exosome and its subgroups.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
12 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

The association of disease recurrence with plasma levels of exosome and its subgroups.

时间窗: 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.

次要结局

  • The change of plasma exosome level during the postoperative surveillance from baseline(through study completion, an average of 2 years)
  • The correlation of microfluidic chip based exosome quantification with conventional approach(through study completion, an average of 2 years)
  • The correlation of the therapeutic response with plasma levels of exosome and its subgroups.(at 1 month post-therapy)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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