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

NCT ID: NCT03108677

Last Updated: 2023-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-01

Study Completion Date

2023-12-30

Brief Summary

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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

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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.

Conditions

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Lung Metastases Osteosarcoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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metastatic

For osteosarcoma patients with metastasis, collecting blood samples.

Blood samples

Intervention Type OTHER

15 ml peripheral blood

non-metastatic

For osteosarcoma patients without metastasis, collecting blood samples.

Blood samples

Intervention Type OTHER

15 ml peripheral blood

Interventions

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Blood samples

15 ml peripheral blood

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ruijin Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yuhui Shen

Ph.D., M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yuhui Shen, Ph.D., M.D.

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital

Weibin Zhang, Ph.D., M.D.

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital

Locations

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Ruijin Hospital Shanghai Jiao Tong University School of medicine

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

References

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Bao 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.

Reference Type DERIVED
PMID: 29981024 (View on PubMed)

Other Identifiers

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RJ2017NO13

Identifier Type: -

Identifier Source: org_study_id

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