Lung MetastasesNCT03108677
Circulating Exosome RNA in Lung Metastases of Primary High-Grade Osteosarcoma
An observational study of Lung Metastases and Osteosarcoma, run by Ruijin Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 60 years
- Conditions the study is for
- Lung Metastases, Osteosarcoma
- What is being tested?
- Blood samples
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2017to 30 Dec 2023
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: patients with primary high-grade osteosarcoma aged 12-60.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site
Ruijin Hospital Shanghai Jiao Tong University School of medicine
Shanghai, Shanghai Municipality, 200025
About this study
Official title: A Pilot Study of Circulating Exosome RNA as Diagnostic and Prognostic Markers in Lung Metastases of Primary High-Grade Osteosarcoma
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.
Read the 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.
- Conditions
- Lung Metastases, Osteosarcoma
- Being tested
- Blood samples
- Keywords
- RNA profiling, Exosome, Lung Metastases, Osteosarcoma
- Medical subject headings
- Osteosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesOther
15 ml peripheral blood
| Study group | Role | What they receive |
|---|---|---|
| metastatic | For osteosarcoma patients with metastasis, collecting blood samples. Receives: Other: Blood samples | |
| non-metastatic | For osteosarcoma patients without metastasis, collecting blood samples. Receives: Other: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Next generation sequencing will be performed to the whole RNA sequencing.
Measured: 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.
Next generation sequencing will be performed to the whole RNA sequencing.
Measured: 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.
Next generation sequencing will be performed to the whole RNA sequencing.
Measured: 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.
Next generation sequencing will be performed to the whole RNA sequencing.
Measured: 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.
Next generation sequencing will be performed to the whole RNA sequencing.
Measured: Before the neo-adjuvant chemotherapy, before the definitive surgery procedure, every 6 months after surgery. up to 3 years.
The mutations of circulating exosome RNA from patients without metastasis.
Next generation sequencing will be performed to the whole RNA sequencing.
Measured: Before the neo-adjuvant chemotherapy, before the definitive surgery procedure, every 6 months after surgery. up to 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start1 May 2017
- Primary completion19 Sep 2023
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung MetastasesStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuhui Shen, Ruijin Hospital
- Investigators
- Yuhui Shen, Ph.D., M.D., Principal investigator, Ruijin HospitalWeibin Zhang, Ph.D., M.D., Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03108677
- Sponsor's protocol ID
- RJ2017NO13
- Status last verified
- Oct 2023
- First submitted
- 5 Apr 2017
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29981024
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Circulating Exosome RNA as Diagnostic and Prognostic Markers in Lung Metastases of Primary High-Grade Osteosarcoma
- ClinicalTrials.gov ID
- NCT03108677
- Acronym / sponsor ID
- RJ2017NO13
- Conditions
- Lung Metastases, Osteosarcoma
- Keywords
- RNA profiling, Exosome, Lung Metastases, Osteosarcoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 19 Sep 2023 (actual)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 11 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| metastatic | – | Other: Blood samplesFor osteosarcoma patients with metastasis, collecting blood samples. |
| non-metastatic | – | Other: Blood samplesFor osteosarcoma patients without metastasis, collecting blood samples. |
Who may qualify
- Ages
- 12 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- patients with primary high-grade osteosarcoma aged 12-60.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samples15 ml peripheral blood | Other | metastatic, non-metastatic |
Primary outcome
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.
6 secondary outcomes
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.
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.
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
- Derived from this study: PubMed 29981024Bao 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuhui Shen, Ph.D., M.D. principal investigator
Ruijin Hospital
Weibin Zhang, Ph.D., M.D. principal investigator
Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Metastases and Osteosarcoma, run by Ruijin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03108677, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2023.