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

Shanghai Jiao Tong University logo

Shanghai Jiao Tong University

Status

Active, not recruiting

Conditions

Osteosarcoma
Lung Metastases

Treatments

Other: Blood samples

Study type

Observational

Funder types

Other

Identifiers

NCT03108677
RJ2017NO13

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 patients

Sex

All

Ages

12 to 60 years old

Volunteers

No 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

Trial design

90 participants in 2 patient groups

metastatic
Description:
For osteosarcoma patients with metastasis, collecting blood samples.
Treatment:
Other: Blood samples
non-metastatic
Description:
For osteosarcoma patients without metastasis, collecting blood samples.
Treatment:
Other: Blood samples

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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