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

Osteosarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05101655
• Other study ID #: (2020)LLS-NO395
• Status: Completed
• Start date: October 1, 2020
• Est. completion date: September 30, 2022

Study information

• Verified date: October 2022
• Source: Ruijin Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Lung Neoplasms
• Neoplasm Metastasis
• Osteosarcoma
• Pulmonary Metastases

Locations

Country	Name	City	State
China	Ruijin Hospital Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

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