Osteosarcoma Clinical Trial
Official title:
Construction and Clinical Application of Microfluidic Exosome Chip for Early Diagnosis of Pulmonary Metastasis of Osteosarcoma
Verified date | October 2022 |
Source | Ruijin Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | September 30, 2022 |
Est. primary completion date | September 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 60 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Ruijin Hospital Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Ruijin Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The association of disease recurrence with plasma levels of exosome and its subgroups. | 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 | |
Secondary | The change of plasma exosome level during the postoperative surveillance from baseline | 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 | |
Secondary | The correlation of the therapeutic response with plasma levels of exosome and its subgroups. | 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 | |
Secondary | The correlation of microfluidic chip based exosome quantification with conventional approach | 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 |
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