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

NCT03108677 | Unknown

• 1 other identifier: RJ2017NO13
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Metastases; Osteosarcoma

Keywords

RNA profiling; Exosome; Lung Metastases; Osteosarcoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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.

• 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.

• 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.

• 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.

• 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.

Study Arms (2)

metastatic

For osteosarcoma patients with metastasis, collecting blood samples.

Other: Blood samples

non-metastatic

For osteosarcoma patients without metastasis, collecting blood samples.

Other: Blood samples

Interventions

Blood samples OTHER

15 ml peripheral blood

metastatic; non-metastatic

Eligibility Criteria

• Age: 12 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

patients with primary high-grade osteosarcoma aged 12-60.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital Shanghai Jiao Tong University School of medicine

Shanghai, Shanghai Municipality, 200025, China

Location

Related Publications (1)

• 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.

  PMID: 29981024 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Samples with purified exosome RNA

MeSH Terms

Conditions

Osteosarcoma

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Yuhui Shen, Ph.D., M.D.

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

• Weibin Zhang, Ph.D., M.D.

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D., M.D.

Study Record Dates

• First Submitted: April 5, 2017
• First Posted: April 11, 2017
• Study Start: May 1, 2017
• Primary Completion: September 19, 2023
• Study Completion: December 30, 2023
• Last Updated: October 3, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)