Construction of Microfluidic Exosome Chip for Diagnosis of Lung Metastasis of Osteosarcoma
Construction and Clinical Application of Microfluidic Exosome Chip for Early Diagnosis of Pulmonary Metastasis of Osteosarcoma
研究概览
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
注册 (实际的)
联系人和位置
学习地点
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Shanghai
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Shanghai、Shanghai、中国、200025
- Ruijin Hospital Shanghai Jiao Tong University School of Medicine
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
- Surgical specimens and peripheral blood specimens of previous patients with osteosarcoma in the specimen bank,
- Patients who were diagnosed with osteosarcoma and were hospitalized in the Department of Orthopedics of Ruijin Hospital
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
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 |
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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
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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.
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through study completion, an average of 2 years
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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The change of plasma exosome level during the postoperative surveillance from baseline
大体时间:through study completion, an average of 2 years
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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.
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through study completion, an average of 2 years
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The correlation of the therapeutic response with plasma levels of exosome and its subgroups.
大体时间:at 1 month post-therapy
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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.
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at 1 month post-therapy
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The correlation of microfluidic chip based exosome quantification with conventional approach
大体时间:through study completion, an average of 2 years
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We investigate the correlation of microfluidic chip based plasma exosome levels with the conventional methodologies, such as Nanoparticle tracking analysis (NTA) and Western-blot
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through study completion, an average of 2 years
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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