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

Sponsor

Ruijin Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT03108677

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Metastases Osteosarcoma	Other: Blood samples

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

40 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

May 1, 2017

Anticipated Primary Completion Date :

May 1, 2022

Anticipated Study Completion Date :

May 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
metastatic For osteosarcoma patients with metastasis, collecting blood samples.	Other: Blood samples 15 ml peripheral blood
non-metastatic For osteosarcoma patients without metastasis, collecting blood samples.	Other: Blood samples 15 ml peripheral blood

Arm

Intervention/Treatment

metastatic

For osteosarcoma patients with metastasis, collecting blood samples.

Other: Blood samples

15 ml peripheral blood

non-metastatic

For osteosarcoma patients without metastasis, collecting blood samples.

Other: Blood samples

15 ml peripheral blood

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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