OsteosarcomaNCT03358628
Patient-derived Xenograft (PDX) Modeling to Test Drug Response for High-grade Osteosarcoma
An observational study of Osteosarcoma, run by Peking University People's Hospital.
Trial summary
By obtaining clinical specimens from participants with high-grade bone and soft tissue sarcomas to establish and profile as freshly implanted tumors in mice, the aim of this study is to identify agents with predicted activity in the host patient while also potentially providing them with individualized cancer… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Osteosarcoma
- What is being tested?
- Molecular Profiling & In Vivo drug testing in PDX
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2018to 31 Jan 2025
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with high-grade osteosarcoma referred to, or being treated at Peking University People's Hostpital.
Who may be able to join
- Age >18 years;
- Diagnosis confirmed histologically and reviewed centrally;
- Prior treatment (completed >4 weeks before trial entry) consisted of standard high-grade osteosarcoma chemotherapy agents including doxorubicin, cisplatin, high-dose methotrexate, and ifosfamide; metastatic relapsed and unresectable progressive disease (PD);
- Eastern Cooperative Oncology Group performance status 0-1 with a life expectancy >3 months;
- Adequate renal, hepatic, and hemopoietic function;
- Normal or controlled blood pressure;
- Surgery and/or radiotherapy completion at least 1 month before enrollment.
Who cannot join
- Central nervous system metastasis;
- Have had other kinds of malignant tumors at the same time;
- Cardiac insufficiency or arrhythmia;
- Uncontrolled complications, such as diabetes mellitus and so on;
- Coagulation disorders;
- Urine protein≥ ++;
- Pleural or peritoneal effusion that needs to be handled by surgical treatment;
- Combined with other infections or wounds.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Patient-derived Xenograft (PDX) Modeling to Test Drug Response for High-grade Osterosarcoma
By obtaining clinical specimens from participants with high-grade bone and soft tissue sarcomas to establish and profile as freshly implanted tumors in mice, the aim of this study is to identify agents with predicted activity in the host patient while also potentially providing them with individualized cancer treatment options
Read the detailed description
Patient-derived xenografts (PDX) are increasingly used as tools for drug development in pre-clinical settings, and have been shown to recapitulate the histology and behavior of the cancers from which they are derived. Although, they have been commonly used productively as pre-clinical disease models to study disease biology and drug response, they have not been used prospectively to inform clinical management. PDX have been employed to inform clinical decision-making in small studies, which have shown high concordance between individual PDX and patient responses to therapy. While encouraging, the role of this approach in bone and soft tissue sarcomas and in the context of genomic drug matching strategies remains undefined. This has created an opportunity to evaluate the utility of PDX as clinical predictors to direct the use of chemo- and targeted therapies in combination with comprehensive genomic and epigenetic analysis for patients with bone and soft tissue sarcomas.
- Conditions
- Osteosarcoma
- Being tested
- Molecular Profiling & In Vivo drug testing in PDX
- Keywords
- Osteosarcoma, Patient-derived xenograft
- Medical subject headings
- Osteosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Molecular Profiling & In Vivo drug testing in PDXOther
Molecular profiling of host tumour sample and PDX will be performed and analyzed by an expert panel. In vitro drug testing using organoid culture generation may also be performed if sufficient fresh tissue is available. Matched treatment recommendation based on profiling and in vivo PDX drug testing results will be made, if available.
| Study group | Role | What they receive |
|---|---|---|
| Osteosarcoma | Osteosarcoma patients with metastatic relapsed or unresectable progressive disease (total n= up to 20) following resection of the primary lesion and adjuvant chemotherapy. Receives: Other: Molecular Profiling & In Vivo drug testing in PDX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of drug sensitive PDX to a panel of drugs as a predictor of clinical response in matched host
Sensitivity measured by tumor growth inhibition (>80%) or objective tumor response (regression) as per Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2017
- Study start1 Feb 2018 (estimated)
- Primary completion31 Jan 2020 (estimated)
- Study completion31 Jan 2025 (estimated)
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 Peking University People's 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GUO WEI, Peking University People's Hospital
- Investigators
- Wei Guo, MD, PhD, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03358628
- Sponsor's protocol ID
- 2017PHB278-01
- Status last verified
- Nov 2017
- First submitted
- 25 Nov 2017
- Last updated
- 30 Nov 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-derived Xenograft (PDX) Modeling to Test Drug Response for High-grade Osterosarcoma
- ClinicalTrials.gov ID
- NCT03358628
- Acronym / sponsor ID
- 2017PHB278-01
- Conditions
- Osteosarcoma
- Keywords
- Osteosarcoma, Patient-derived xenograft
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Feb 2018 (estimated)
- Primary completion
- 31 Jan 2020 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 30 Nov 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.
By obtaining clinical specimens from participants with high-grade bone and soft tissue sarcomas to establish and profile as freshly implanted tumors in mice, the aim of this study is to identify agents with predicted activity in the host patient while also potentially providing them with individualized cancer treatment options
Detailed description
Patient-derived xenografts (PDX) are increasingly used as tools for drug development in pre-clinical settings, and have been shown to recapitulate the histology and behavior of the cancers from which they are derived. Although, they have been commonly used productively as pre-clinical disease models to study disease biology and drug response, they have not been used prospectively to inform clinical management. PDX have been employed to inform clinical decision-making in small studies, which have shown high concordance between individual PDX and patient responses to therapy. While encouraging, the role of this approach in bone and soft tissue sarcomas and in the context of genomic drug matching strategies remains undefined. This has created an opportunity to evaluate the utility of PDX as clinical predictors to direct the use of chemo- and targeted therapies in combination with comprehensive genomic and epigenetic analysis for patients with bone and soft tissue sarcomas.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Osteosarcoma | – | Other: Molecular Profiling & In Vivo drug testing in PDXOsteosarcoma patients with metastatic relapsed or unresectable progressive disease (total n= up to 20) following resection of the primary lesion and adjuvant chemotherapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with high-grade osteosarcoma referred to, or being treated at Peking University People's Hostpital.
Key inclusion criteria (7 listed)
- Age >18 years;
- Diagnosis confirmed histologically and reviewed centrally;
- Prior treatment (completed >4 weeks before trial entry) consisted of standard high-grade osteosarcoma chemotherapy agents including doxorubicin, cisplatin, high-dose methotrexate, and ifosfamide; metastatic relapsed and unresectable progressive disease (PD);
- Eastern Cooperative Oncology Group performance status 0-1 with a life expectancy >3 months;
- Adequate renal, hepatic, and hemopoietic function;
Key exclusion criteria (8 listed)
- Central nervous system metastasis;
- Have had other kinds of malignant tumors at the same time;
- Cardiac insufficiency or arrhythmia;
- Uncontrolled complications, such as diabetes mellitus and so on;
- Coagulation disorders;
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 |
|---|---|---|
| Molecular Profiling & In Vivo drug testing in PDXMolecular profiling of host tumour sample and PDX will be performed and analyzed by an expert panel. In vitro drug testing using organoid culture generation may also be performed if sufficient fresh tissue is available. Matched treatment recommendation based on profiling and in vivo PDX drug testing results will be made, if available. | Other | Osteosarcoma |
Primary outcome
Measure of drug sensitive PDX to a panel of drugs as a predictor of clinical response in matched host
Time frame: up to 2 years
Sensitivity measured by tumor growth inhibition (>80%) or objective tumor response (regression) as per Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2017.
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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.
Wei Guo, MD, PhD principal investigator
Peking University People's Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Osteosarcoma, run by Peking University People's Hospital.
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 7 inclusion and 8 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 30 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Tingting Ren, PhD (86-10-88324470, tumorcenter@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of drug sensitive PDX to a panel of drugs as a predictor of clinical response in matched host (time frame: up to 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 30 Nov 2017.