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Trial record 21 of 125 for:    Recruiting, Not yet recruiting, Available Studies | "Osteosarcoma"

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

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ClinicalTrials.gov Identifier: NCT03108677
Recruitment Status : Recruiting
First Posted : April 11, 2017
Last Update Posted : May 31, 2017
Sponsor:
Information provided by (Responsible Party):
Yuhui Shen, Ruijin Hospital

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
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 Type : Observational [Patient Registry]
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
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
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine


Group/Cohort 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




Primary Outcome Measures :
  1. Differences in the levels and mutations of circulating exosome RNA from patients with or without lung metastasis. [ Time Frame: 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 :
  1. Differences in the classic cell signal pathway mutations of circulating exosome RNA from patients with or without lung metastasis. [ Time Frame: 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.

  2. Differences in the therapeutic targets mutations of circulating exosome RNA from patients with or without lung metastasis. [ Time Frame: 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.

  3. The correlation between circulating exosome RNA mutation levels and 3-year disease-free survival (DFS), progression-free survival (PFS), lung metastases. [ Time Frame: 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.

  4. The correlation between specific circulating exosome RNA mutations and 3-year disease-free survival (DFS), progression-free survival (PFS), lung metastases. [ Time Frame: 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.

  5. The roles of circulating exosome micro-RNA mutations on regulation of circulating exosome RNA. [ Time Frame: 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.

  6. The mutations of circulating exosome RNA from patients without metastasis. [ Time Frame: 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.


Biospecimen Retention:   Samples Without DNA
Samples with purified exosome RNA


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Ages Eligible for Study:   12 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with primary high-grade osteosarcoma aged 12-60.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03108677


Contacts
Contact: Yuhui Shen, Ph.D., M.D. +8613918209875 yuhuiss@163.com

Locations
China, Shanghai
Ruijin Hospital Shanghai Jiao Tong University School of medicine Recruiting
Shanghai, Shanghai, China, 200025
Contact: Yuhui Shen, Ph.D., M.D.    +8613918209875    yuhuiss@163.com   
Principal Investigator: Yuhui Shen, Ph.D., M.D.         
Principal Investigator: Weibin Zhang, Ph.D., M.D.         
Sub-Investigator: Fangzhou He, M.D.         
Sub-Investigator: Qiyuan Bao, Ph.D., M.D.         
Sponsors and Collaborators
Ruijin Hospital
Investigators
Principal Investigator: Yuhui Shen, Ph.D., M.D. Ruijin Hospital
Principal Investigator: Weibin Zhang, Ph.D., M.D. Ruijin Hospital

Responsible Party: Yuhui Shen, Ph.D., M.D., Ruijin Hospital
ClinicalTrials.gov Identifier: NCT03108677     History of Changes
Other Study ID Numbers: RJ2017NO13
First Posted: April 11, 2017    Key Record Dates
Last Update Posted: May 31, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yuhui Shen, Ruijin Hospital:
RNA profiling
Exosome
Lung Metastases
Osteosarcoma

Additional relevant MeSH terms:
Osteosarcoma
Neoplasm Metastasis
Neoplasms, Second Primary
Lung Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Sarcoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases