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

NCT ID: NCT05101655

Last Updated: 2022-11-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2022-09-30

Brief Summary

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.

Detailed Description

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.

Conditions

Osteosarcoma; Pulmonary Metastases

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ruijin Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

(2020)LLS-NO395

Identifier Type: -

Identifier Source: org_study_id