ProgressionNCT03582527
PD-L1 Expression in Advanced Osteosarcoma
An observational study of Progression and Survival, run by Peking University People's Hospital at 1 site in China.
Trial summary
The expression level of PD-L1 on tumor cells is a pivotal point which might have some influence on prognosis, especially for those who might use PD-1 or PD-L1 antibody for treatment. The aim of this study is to detect the expression of PD-1 on advaced osteosarcoma patient who might use these antibodies for treatment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Progression, Survival
- What is being tested?
- all study participants
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2018to 15 Feb 2020
- How long will I take part?
- 2 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: All those advanced osteosarcoma patients who intend to receive anti-PD-1/anti-PD-L1 therapy.
Who may be able to join
- diagnosis confirmed histologically and reviewed centrally;
- received surgery in Musculoskeletal Tumor Center of Peking University People's Hospital with appropriate sample for immunohistochemical staining;
- progressing upon 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);
- having measurable lesion according to RECIST 1.1;
- Eastern Cooperative Oncology Group performance status 0-1 with a life expectancy >3 months;
- intend to receive anti-PD-1/anti-PD-L1 antibody for therapy.
Who cannot join
- fail to be followed up regularly.
- sample disqualification.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Musculoskeletal Tumor Center of Peking University People's Hospital
Beijing, Beijing Municipality, 100
Tingting Ren, Ph.D.
Wei Guo, M.D. and Ph.D.
About this study
Official title: The Expression of Programmed Death Ligand-1 (PD-L1) on Advanced Osteosarcoma Tissue and Its Influence on Prognosis
The expression level of PD-L1 on tumor cells is a pivotal point which might have some influence on prognosis, especially for those who might use PD-1 or PD-L1 antibody for treatment. The aim of this study is to detect the expression of PD-1 on advaced osteosarcoma patient who might use these antibodies for treatment. All those specimen should be taken by pathologist and confirmed with high tumor cellularity.
- Conditions
- Progression, Survival
- Being tested
- all study participants
- Keywords
- osteosarcoma, refractory to chemotherapy, unresectable, PD-L1, VENTANA PD-L1 (SP263)
- Medical subject headings
- Disease Progression, Osteosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
all study participantsOther
patients will receive anti-PD-1/anti-PD-L1 antibody for further treatment
| Study group | Role | What they receive |
|---|---|---|
| observation group | All these patients who have been tested will be observed for further treatment and been recorded for toxicity. Receives: Other: all study participants |
What is being measured
The primary outcome is the main question the study is designed to answer.
PD-L1 expression level
all those specimens will be tested for expression level,Tumors with ≥50% cells showing positive membrane staining were considered to have high expression of PD-L1
Measured: 2 months
Secondary outcomes (2)
progression free survival
from the timing of testing to disease progression/death whichever comes first
Measured: 2 years
overall survival
from the timing of testing to death/last follow-up
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2018
- Study start1 Jun 2018
- Primary completion31 Dec 2019 (estimated)
- Study completion15 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProgressionStudies of the same condition, open and under way.
- 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
- 50 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03582527
- Sponsor's protocol ID
- PKUPH-sarcoma 03
- Status last verified
- Jul 2018
- First submitted
- 10 Jun 2018
- Last updated
- 1 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Expression of Programmed Death Ligand-1 (PD-L1) on Advanced Osteosarcoma Tissue and Its Influence on Prognosis
- ClinicalTrials.gov ID
- NCT03582527
- Acronym / sponsor ID
- PKUPH-sarcoma 03
- Conditions
- Progression, Survival
- Keywords
- osteosarcoma, refractory to chemotherapy, unresectable, PD-L1, VENTANA PD-L1 (SP263)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 15 Feb 2020 (estimated)
- First posted
- 11 Jul 2018 (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 expression level of PD-L1 on tumor cells is a pivotal point which might have some influence on prognosis, especially for those who might use PD-1 or PD-L1 antibody for treatment. The aim of this study is to detect the expression of PD-1 on advaced osteosarcoma patient who might use these antibodies for treatment. All those specimen should be taken by pathologist and confirmed with high tumor cellularity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| observation group | – | Other: all study participantsAll these patients who have been tested will be observed for further treatment and been recorded for toxicity. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- All those advanced osteosarcoma patients who intend to receive anti-PD-1/anti-PD-L1 therapy.
Key inclusion criteria (6 listed)
- diagnosis confirmed histologically and reviewed centrally;
- received surgery in Musculoskeletal Tumor Center of Peking University People's Hospital with appropriate sample for immunohistochemical staining;
- progressing upon 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);
- having measurable lesion according to RECIST 1.1;
- Eastern Cooperative Oncology Group performance status 0-1 with a life expectancy >3 months;
Key exclusion criteria (2 listed)
- fail to be followed up regularly.
- sample disqualification.
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 |
|---|---|---|
| all study participantspatients will receive anti-PD-1/anti-PD-L1 antibody for further treatment | Other | observation group |
Primary outcome
PD-L1 expression level
Time frame: 2 months
all those specimens will be tested for expression level,Tumors with ≥50% cells showing positive membrane staining were considered to have high expression of PD-L1
2 secondary outcomes
progression free survival
Time frame: 2 years
overall survival
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2018.
- 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.
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 Progression and Survival, run by Peking University People's 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 6 inclusion and 2 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 1 Aug 2018. 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?
Contact Lu Xie, M.D. (+86-13401044719, sweetdoctor@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PD-L1 expression level (time frame: 2 months). 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 1 Aug 2018.