Clinical trial · Observational
Circulating Exosome RNA in Lung Metastases of Primary High-Grade Osteosarcoma
A Pilot Study of Circulating Exosome RNA as Diagnostic and Prognostic Markers in Lung Metastases of Primary High-Grade Osteosarcoma
NCT03108677CI-TRIAL-00070132unknownClinicalTrials.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)
The purpose of this study is to learn whether the profile of RNA from circulating exosomes can be used as a biomarker for lung metastases of primary high-grade osteosarcoma. Circulating exosomes plays roles in metastases in many kinds of cancer including osteosarcoma. By RNA profiling researchers may find lung metastases earlier than conventional work-up and predict the oncological outcomes.
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 |
|---|---|---|---|
| Lung Metastases | — | UNRESOLVED | — |
| Osteosarcoma | Osteosarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood samples | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- metastatic
- description
- For osteosarcoma patients with metastasis, collecting blood samples.
- interventionNames
- Other: Blood samples
- label
- non-metastatic
- description
- For osteosarcoma patients without metastasis, collecting blood samples.
- interventionNames
- Other: Blood samples
Primary outcomes (1)
- measure
- Differences in the levels and mutations of circulating exosome RNA from patients with or without lung metastasis.
- timeFrame
- Before the neo-adjuvant chemotherapy, before the definitive surgery procedure, every 6 months after surgery. up to 3 years.
- description
- Next generation sequencing will be performed to the whole RNA sequencing.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis by biopsy: primary high-grade osteosarcoma, including conventional osteosarcoma, telangiectatic osteosarcoma, small cell osteosarcoma, high-grade surface osteosarcoma. * Tumor located in the extremities or pelvis. * Age 12-60 years. * No prior history of cancer and no prior treatment elsewhere. * No prior history of chronic diseases including autoimmune disease, chronic infection, etc. which may interfere the level of circulating exosomes. Exclusion Criteria: * Initial misdiagnosis confirmed by specimen of definitive surgery. * Applying target drugs in the period of treatment which may reduce tumor derived exosomes * withdraw from the study for any reason
References
Publications (1)
- DERIVEDBao Q, Gong L, Wang J, Wen J, Shen Y, Zhang W. Extracellular Vesicle RNA Sequencing Reveals Dramatic Transcriptomic Alterations Between Metastatic and Primary Osteosarcoma in a Liquid Biopsy Approach. Ann Surg Oncol. 2018 Sep;25(9):2642-2651. doi: 10.1245/s10434-018-6642-z. Epub 2018 Jul 6. PMID 29981024