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

Osteosarcoma Clinical Trial

Official title:

A Pilot Study of Circulating Exosome RNA as Diagnostic and Prognostic Markers in Lung Metastases of Primary High-Grade Osteosarcoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03108677
• Other study ID #: RJ2017NO13
• Status: Active, not recruiting
• Start date: May 1, 2017
• Est. completion date: December 30, 2023

Study information

• Verified date: October 2023
• Source: Ruijin Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: December 30, 2023
• Est. primary completion date: September 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Metastases
• Lung Neoplasms
• Neoplasm Metastasis
• Osteosarcoma

Intervention

Other:
• Blood samples
15 ml peripheral blood

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