Circulating Exosome RNA in Lung Metastases of Primary High-Grade Osteosarcoma

Active, not recruiting

• Conditions: Lung Metastases; Osteosarcoma
• Interventions: Other: Blood samples

• Registration Number: NCT03108677
• Lead Sponsor: Ruijin Hospital

Brief Summary

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.

Detailed Description

Investigators have performed a 4 patients pilot study under the oversight of hospital's ethics committee, and investigator found that the levels and mutations of circulating exosome RNA from patients with or without lung metastasis have significant differences. Then investigators wish to register this study to do a further research, in order to reveal the roles of circulating exosome RNA in metastases of osteosarcoma.

Study Timeline

• Study First Submitted: 2017-04-05
• Study First Submitted QC: 2017-04-10
• Study First Posted: 2017-04-11
• Study Start: 2017-05-01
• Primary Completion: 2023-09-19
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-02
• Last Update Posted: 2023-10-03
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
metastatic	Blood samples	For osteosarcoma patients with metastasis, collecting blood samples.
non-metastatic	Blood samples	For osteosarcoma patients without metastasis, collecting blood samples.

Primary Outcome Measures

Name	Time	Method
Differences in the levels and mutations of circulating exosome RNA from patients with or without lung metastasis.	Before the neo-adjuvant chemotherapy, before the definitive surgery procedure, every 6 months after surgery. up to 3 years.	Next generation sequencing will be performed to the whole RNA sequencing.

Secondary Outcome Measures

Name	Time	Method
Differences in the classic cell signal pathway mutations of circulating exosome RNA from patients with or without lung metastasis.	Before the neo-adjuvant chemotherapy, before the definitive surgery procedure, every 6 months after surgery. up to 3 years.	Next generation sequencing will be performed to the whole RNA sequencing.
Differences in the therapeutic targets mutations of circulating exosome RNA from patients with or without lung metastasis.	Before the neo-adjuvant chemotherapy, before the definitive surgery procedure, every 6 months after surgery. up to 3 years.	Next generation sequencing will be performed to the whole RNA sequencing.
The correlation between circulating exosome RNA mutation levels and 3-year disease-free survival (DFS), progression-free survival (PFS), lung metastases.	Before the neo-adjuvant chemotherapy, before the definitive surgery procedure, every 6 months after surgery. up to 3 years.	Next generation sequencing will be performed to the whole RNA sequencing.
The correlation between specific circulating exosome RNA mutations and 3-year disease-free survival (DFS), progression-free survival (PFS), lung metastases.	Before the neo-adjuvant chemotherapy, before the definitive surgery procedure, every 6 months after surgery. up to 3 years.	Next generation sequencing will be performed to the whole RNA sequencing.
The roles of circulating exosome micro-RNA mutations on regulation of circulating exosome RNA.	Before the neo-adjuvant chemotherapy, before the definitive surgery procedure, every 6 months after surgery. up to 3 years.	Next generation sequencing will be performed to the whole RNA sequencing.
The mutations of circulating exosome RNA from patients without metastasis.	Before the neo-adjuvant chemotherapy, before the definitive surgery procedure, every 6 months after surgery. up to 3 years.	Next generation sequencing will be performed to the whole RNA sequencing.

Trial Locations

Locations (1)

Ruijin Hospital Shanghai Jiao Tong University School of medicine; 🇨🇳 Shanghai, Shanghai, China