OsteosarcomaNCT05101655
Construction of Microfluidic Exosome Chip for Diagnosis of Lung Metastasis of Osteosarcoma
An observational study of Osteosarcoma and Pulmonary Metastases, run by Ruijin Hospital at 1 site in China.
Trial summary
Use exosome microfluidic chips to establish a combination of exosome subgroup level (exosome barcode) markers for the early diagnosis of osteosarcoma lung recurrence, and establish the basis of microfluidic chip based exosome biomarker for monitoring the early therapeutic response of the second-line therapy for… Read more about this study
- Who is it for?
- Ages 12 to 60 years
- Conditions the study is for
- Osteosarcoma, Pulmonary Metastases
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2020to 30 Sep 2022
- 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: 1. Surgical specimens and peripheral blood specimens of previous patients with osteosarcoma in the specimen bank, 2. Patients who were diagnosed with osteosarcoma and were hospitalized in the Department of Orthopedics of Ruijin Hospital
Who may be able to join
- Biopsy pathologically diagnosed as primary high-grade osteosarcoma (including ordinary osteosarcoma, vasodilatory osteosarcoma, small cell osteosarcoma, high-grade surface osteosarcoma);
- Age no less than 12 years old and no older than 60 years old;
- New-onset patients who have not received chemotherapy, radiotherapy, surgery, Chinese medicine and other treatments.
- The primary site is the limbs and pelvis.
Who cannot join
- Pathological diagnosis of surgical gross specimens except primary high-grade osteosarcoma;
- Failure to collect circulating exosomes as planned;
- Suffering from chronic diseases, which may lead to an increase in non-tumor-related circulating exosomes, such as autoimmune diseases , Chronic infections, etc.;
- The use of targeted drugs may lead to a decrease in tumor-related circulating exosomes;
- Withdrawal from the trial 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: Construction and Clinical Application of Microfluidic Exosome Chip for Early Diagnosis of Pulmonary Metastasis of Osteosarcoma
Use exosome microfluidic chips to establish a combination of exosome subgroup level (exosome barcode) markers for the early diagnosis of osteosarcoma lung recurrence, and establish the basis of microfluidic chip based exosome biomarker for monitoring the early therapeutic response of the second-line therapy for recurrent osteosarcoma.
Read the detailed description
Osteosarcoma is the most common primary malignant bone tumor in adolescents, and lung metastasis is the main cause of its poor prognosis. Our previous data on the basis of second-line chemotherapy combined with VEGFRi targeted therapy for patients with lung metastases from osteosarcoma showed that some patients with early diagnosis of lung metastases may achieved long-term tumor-free survival upon prompt treatment. However, plasma biomarker for the early detection of recurrent osteosarcoma is still lacking to date. Our preliminary studies indicate that exosome is a potential source of liquid biomarker for the early diagnosis of osteosarcoma lung metastasis. We, therefore, have developed a microfluidic biochip based on nano-zinc oxide microcolumns. This chip can quickly and efficiently screen and capture exosomes and achieve quantitative and qualitative detection of exosome and its subgroups. This technology may be able to achieve early sensitive exosome quantification for lung metastasis of osteosarcoma. But the clinical efficacy and utility of the microfluidic chip based exosome detection for the early diagnosis osteosarcoma recurrence remains to be validated.
This research plan uses our newly developed microfluidic chip technology to capture and efficiently capture exosomes for quantitative and qualitative and marker screening, and establish a combination of exosome subgroups level as a biomarker for the early diagnosis of osteosarcoma lung metastasis.
- Conditions
- Osteosarcoma, Pulmonary Metastases
- Medical subject headings
- Osteosarcoma
What is being measured
The primary outcome is the main question the study is designed to answer.
The association of disease recurrence with plasma levels of exosome and its subgroups.
After the patients were enrolled, MRI of the primary surgical site (enhanced if necessary), chest CT and bone scan were performed for the surveillance of disease recurrence according to the National Comprehensive Cancer Network (NCCN) guideline. The number of total plasma exosome as well as its subgroups (Vim, cluster of differentiation 44 (CD44), Integrins positive, etc.) were measured based on the microfluidic chip. The association of sarcoma recurrence with plasma exosome levels was then determined to validate the clinical efficacy of plasma exosome as a potential liquid biomarker.
Measured: through study completion, an average of 2 years
Secondary outcomes (3)
The change of plasma exosome level during the postoperative surveillance from baseline
The exosome and its subgroup levels were measured on the individual basis in comparison to the baseline to study the dynamic change of exosome during the postoperative surveillance from baseline.
Measured: through study completion, an average of 2 years
The correlation of the therapeutic response with plasma levels of exosome and its subgroups.
For patients with recurrent disease who start second- or third- line therapy, the number of total plasma exosome as well as its subgroups (Vim, cluster of differentiation 44 (CD44), Integrins positive, etc.) were measured at 1 month post-therapy. We then assess the association of the exosome biomarker with the treatment response, as determined by Response Evaluation Criteria In Solid Tumours (RECIST) 1.1.
Measured: at 1 month post-therapy
The correlation of microfluidic chip based exosome quantification with conventional approach
We investigate the correlation of microfluidic chip based plasma exosome levels with the conventional methodologies, such as Nanoparticle tracking analysis (NTA) and Western-blot
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2021
- Study start1 Oct 2020
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteosarcomaStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05101655
- Sponsor's protocol ID
- (2020)LLS-NO395
- Status last verified
- Oct 2022
- First submitted
- 7 Oct 2021
- Last updated
- 15 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction and Clinical Application of Microfluidic Exosome Chip for Early Diagnosis of Pulmonary Metastasis of Osteosarcoma
- ClinicalTrials.gov ID
- NCT05101655
- Acronym / sponsor ID
- (2020)LLS-NO395
- Conditions
- Osteosarcoma, Pulmonary Metastases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 1 Nov 2021 (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.
Use exosome microfluidic chips to establish a combination of exosome subgroup level (exosome barcode) markers for the early diagnosis of osteosarcoma lung recurrence, and establish the basis of microfluidic chip based exosome biomarker for monitoring the early therapeutic response of the second-line therapy for recurrent osteosarcoma.
Detailed description
Osteosarcoma is the most common primary malignant bone tumor in adolescents, and lung metastasis is the main cause of its poor prognosis. Our previous data on the basis of second-line chemotherapy combined with VEGFRi targeted therapy for patients with lung metastases from osteosarcoma showed that some patients with early diagnosis of lung metastases may achieved long-term tumor-free survival upon prompt treatment. However, plasma biomarker for the early detection of recurrent osteosarcoma is still lacking to date. Our preliminary studies indicate that exosome is a potential source of liquid biomarker for the early diagnosis of osteosarcoma lung metastasis. We, therefore, have developed a microfluidic biochip based on nano-zinc oxide microcolumns. This chip can quickly and efficiently screen and capture exosomes and achieve quantitative and qualitative detection of exosome and its subgroups. This technology may be able to achieve early sensitive exosome quantification for lung metastasis of osteosarcoma. But the clinical efficacy and utility of the microfluidic chip based exosome detection for the early diagnosis osteosarcoma recurrence remains to be validated.
This research plan uses our newly developed microfluidic chip technology to capture and efficiently capture exosomes for quantitative and qualitative and marker screening, and establish a combination of exosome subgroups level as a biomarker for the early diagnosis of osteosarcoma lung metastasis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- 1. Surgical specimens and peripheral blood specimens of previous patients with osteosarcoma in the specimen bank, 2. Patients who were diagnosed with osteosarcoma and were hospitalized in the Department of Orthopedics of Ruijin Hospital
Key inclusion criteria (4 listed)
- Biopsy pathologically diagnosed as primary high-grade osteosarcoma (including ordinary osteosarcoma, vasodilatory osteosarcoma, small cell osteosarcoma, high-grade surface osteosarcoma);
- Age no less than 12 years old and no older than 60 years old;
- New-onset patients who have not received chemotherapy, radiotherapy, surgery, Chinese medicine and other treatments.
- The primary site is the limbs and pelvis.
Key exclusion criteria (5 listed)
- Pathological diagnosis of surgical gross specimens except primary high-grade osteosarcoma;
- Failure to collect circulating exosomes as planned;
- Suffering from chronic diseases, which may lead to an increase in non-tumor-related circulating exosomes, such as autoimmune diseases , Chronic infections, etc.;
- The use of targeted drugs may lead to a decrease in tumor-related circulating exosomes;
- Withdrawal from the trial 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.
Primary outcome
The association of disease recurrence with plasma levels of exosome and its subgroups.
Time frame: through study completion, an average of 2 years
After the patients were enrolled, MRI of the primary surgical site (enhanced if necessary), chest CT and bone scan were performed for the surveillance of disease recurrence according to the National Comprehensive Cancer Network (NCCN) guideline. The number of total plasma exosome as well as its subgroups (Vim, cluster of differentiation 44 (CD44), Integrins positive, etc.) were measured based on the microfluidic chip. The association of sarcoma recurrence with plasma exosome levels was then determined to validate the clinical efficacy of plasma exosome as a potential liquid biomarker.
3 secondary outcomes
The change of plasma exosome level during the postoperative surveillance from baseline
Time frame: through study completion, an average of 2 years
The correlation of the therapeutic response with plasma levels of exosome and its subgroups.
Time frame: at 1 month post-therapy
The correlation of microfluidic chip based exosome quantification with conventional approach
Time frame: through study completion, an average of 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Osteosarcoma and Pulmonary Metastases, 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 15 Nov 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The association of disease recurrence with plasma levels of exosome and its subgroups. (time frame: through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Nov 2022.