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

NCT05101655 | Completed DMC

• 1 other identifier: (2020)LLS-NO395
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteosarcoma; Pulmonary Metastases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The change of plasma exosome level during the postoperative surveillance from baseline

  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

• The correlation of microfluidic chip based exosome quantification with conventional approach

  through study completion, an average of 2 years

Eligibility Criteria

• Age: 12 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

1. Surgical specimens and peripheral blood specimens of previous patients with osteosarcoma in the specimen bank, 2. Patients who were diagnosed with osteosarcoma and were hospitalized in the Department of Orthopedics of Ruijin Hospital

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

MeSH Terms

Conditions

Osteosarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2021
• First Posted: November 1, 2021
• Study Start: October 1, 2020
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: November 15, 2022

Record last verified: 2022-10

Locations

CN (1)