Clinical trial · Observational
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
NCT05101655CI-TRIAL-00062192completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Osteosarcoma | Osteosarcoma | ONTOLOGY_EXACT | 0.90 |
| Pulmonary Metastases | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- The association of disease recurrence with plasma levels of exosome and its subgroups.
- timeFrame
- through study completion, an average of 2 years
- description
- 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.
Secondary outcomes (3)
- measure
- The change of plasma exosome level during the postoperative surveillance from baseline
- timeFrame
- through study completion, an average of 2 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.