Clinical trial NCT03108677: Circulating Exosome RNA in Lung Metastases of Primary High-Grade Osteosarcoma
Official title: A Pilot Study of Circulating Exosome RNA as Diagnostic and Prognostic Markers in Lung Metastases of Primary High-Grade Osteosarcoma
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Lung Metastases
Osteosarcoma
Keywords: RNA profiling
Exosome
Lung Metastases
Osteosarcoma
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2017-04-11
Enrollment: 90
Sex: ALL
Minimum age (years): 12
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with primary high-grade osteosarcoma aged 12-60.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Differences in the levels and mutations of circulating exosome RNA from patients with or without lung metastasis.
timeFrame: Before the neo-adjuvant chemotherapy, before the definitive surgery procedure, every 6 months after surgery. up to 3 years.
Secondary outcomes:
measure: Differences in the classic cell signal pathway mutations of circulating exosome RNA from patients with or without lung metastasis.
timeFrame: Before the neo-adjuvant chemotherapy, before the definitive surgery procedure, every 6 months after surgery. up to 3 years.
measure: Differences in the therapeutic targets mutations of circulating exosome RNA from patients with or without lung metastasis.
timeFrame: Before the neo-adjuvant chemotherapy, before the definitive surgery procedure, every 6 months after surgery. up to 3 years.
measure: The correlation between circulating exosome RNA mutation levels and 3-year disease-free survival (DFS), progression-free survival (PFS), lung metastases.
timeFrame: Before the neo-adjuvant chemotherapy, before the definitive surgery procedure, every 6 months after surgery. up to 3 years.
measure: The correlation between specific circulating exosome RNA mutations and 3-year disease-free survival (DFS), progression-free survival (PFS), lung metastases.
timeFrame: Before the neo-adjuvant chemotherapy, before the definitive surgery procedure, every 6 months after surgery. up to 3 years.
measure: The roles of circulating exosome micro-RNA mutations on regulation of circulating exosome RNA.
timeFrame: Before the neo-adjuvant chemotherapy, before the definitive surgery procedure, every 6 months after surgery. up to 3 years.
measure: The mutations of circulating exosome RNA from patients without metastasis.
timeFrame: Before the neo-adjuvant chemotherapy, before the definitive surgery procedure, every 6 months after surgery. up to 3 years.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital Shanghai Jiao Tong University School of medicine
state: Shanghai
Study officials:
affiliation: Ruijin Hospital
name: Yuhui Shen, Ph.D., M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ruijin Hospital
name: Weibin Zhang, Ph.D., M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.