OsteosarcomaPTMTONCT06776198
Precision Therapy Based on Immune Microenvironment by Transcriptome Sequencing of Osteosarcoma, a Prospective, Multi-cohort Exploratory Clinical Study
An observational study of Osteosarcoma and Transcriptome, run by Peking University People's Hospital.
Trial summary
Bagaev et al. have identified four tumor microenvironment (TME) subtypes that are conserved across diverse cancers and correlated with immunotherapy response in melanoma, bladder, and gastric cancers. Read more about this study
- Who is it for?
- Ages 8 to 70 years
- Conditions the study is for
- Osteosarcoma, Transcriptome, Tumor Microenvironment
- What is being tested?
- Chemotherapy
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to 1 Jun 2027
- How long will I take part?
- 100 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 8 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Initially treated osteosarcoma
Who may be able to join
- (i) patients who have been suspected for osteosarcoma with enough clinical or radiographic information;
- (ii) patients who have evaluable lesions to resect or follow;
- (iii) patients who are planned to be operate with enough flesh specimens for this study.
Who cannot join
- (i) clinical information was not complete;
- (ii) lost to follow-up.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Bagaev et al. have identified four tumor microenvironment (TME) subtypes that are conserved across diverse cancers and correlated with immunotherapy response in melanoma, bladder, and gastric cancers. They provided a visual tool revealing the TME subtypes integrated with targetable genomic alterations, which provided a planetary view of each tumor that can aid in oncology clinical decision making. We aim to use this tool to prospectively analyse the biopsy specimens of osteosarcomas to identify their TME subtypes so as to deliver appropriate treatment strategy if these osteosarcomas experience disease progression afterwards. We will compare the past sequencing date stored in PKUPH bank so as to compare the event-free survival(EFS) of these patients to check the Superiority of this method later.
- Being tested
- Chemotherapy
- Keywords
- osteosarcoma, transcriptome, tumor microenviroment, precision medicine
- Medical subject headings
- Osteosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemotherapyDrug
Group IE/F: After progression, try LRRC15 ADC + PD-1 inhibitors; Group IE: After progression, try simple anti-PD-1 inhibitors; Group F: After progression, try LRRC15 ADC; Group D: After progression, try B7-H3 ADC or other irrinotecan analogue
| Study group | Role | What they receive |
|---|---|---|
| Immune-Enriched, Fibrotic Group (IE/F) | Not described Receives: Drug: Chemotherapy | |
| Immune-Enriched, Non-Fibrotic Group (IE) | Not described Receives: Drug: Chemotherapy | |
| Fibrotic Group (F) | Not described Receives: Drug: Chemotherapy | |
| Depleted Group (D) | Not described Receives: Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free Survival (EFS)
From biopsy to progression/last follow-up
Measured: 2 year
Secondary outcomes (1)
Event-free Survival (EFS) for the second time
From first progression to the second progression/last follow-up
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start1 Mar 2025 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Jun 2027 (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 OsteosarcomaStudies 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
- 100 participants (estimated)
- Target duration
- 100 Years
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xie Lu, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06776198
- Sponsor's protocol ID
- PKUPH-sarcoma 21
- Acronym
- PTMTO
- Status last verified
- Jan 2025
- First submitted
- 10 Jan 2025
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bagaev A, Kotlov N, Nomie K, Svekolkin V, Gafurov A, Isaeva O, Osokin N, Kozlov I, Frenkel F, Gancharova O, Almog N, Tsiper M, Ataullakhanov R, Fowler N. Conserved pan-cancer microenvironment subtypes predict response to immunotherapy. Cancer Cell. 2021 Jun 14;39(6):845-865.e7. doi: 10.1016/j.ccell.2021.04.014. Epub 2021 May 20.
PubMed 34019806
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Therapy Based on Immune Microenvironment by Transcriptome Sequencing of Osteosarcoma, a Prospective, Multi-cohort Exploratory Clinical Study
- ClinicalTrials.gov ID
- NCT06776198
- Acronym / sponsor ID
- PTMTO / PKUPH-sarcoma 21
- Keywords
- osteosarcoma, transcriptome, tumor microenviroment, precision medicine
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 15 Jan 2025 (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.
Bagaev et al. have identified four tumor microenvironment (TME) subtypes that are conserved across diverse cancers and correlated with immunotherapy response in melanoma, bladder, and gastric cancers. They provided a visual tool revealing the TME subtypes integrated with targetable genomic alterations, which provided a planetary view of each tumor that can aid in oncology clinical decision making. We aim to use this tool to prospectively analyse the biopsy specimens of osteosarcomas to identify their TME subtypes so as to deliver appropriate treatment strategy if these osteosarcomas experience disease progression afterwards. We will compare the past sequencing date stored in PKUPH bank so as to compare the event-free survival(EFS) of these patients to check the Superiority of this method later.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 100 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Immune-Enriched, Fibrotic Group (IE/F) | – | Drug: Chemotherapy |
| Immune-Enriched, Non-Fibrotic Group (IE) | – | Drug: Chemotherapy |
| Fibrotic Group (F) | – | Drug: Chemotherapy |
| Depleted Group (D) | – | Drug: Chemotherapy |
Who may qualify
- Ages
- 8 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Initially treated osteosarcoma
Key inclusion criteria (3 listed)
- (i) patients who have been suspected for osteosarcoma with enough clinical or radiographic information;
- (ii) patients who have evaluable lesions to resect or follow;
- (iii) patients who are planned to be operate with enough flesh specimens for this study.
Key exclusion criteria (2 listed)
- (i) clinical information was not complete;
- (ii) lost to follow-up.
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 |
|---|---|---|
| ChemotherapyGroup IE/F: After progression, try LRRC15 ADC + PD-1 inhibitors; Group IE: After progression, try simple anti-PD-1 inhibitors; Group F: After progression, try LRRC15 ADC; Group D: After progression, try B7-H3 ADC or other irrinotecan analogue | Drug | Depleted Group (D), Fibrotic Group (F), Immune-Enriched, Fibrotic Group (IE/F), Immune-Enriched, Non-Fibrotic Group (IE) |
Primary outcome
Event-free Survival (EFS)
Time frame: 2 year
From biopsy to progression/last follow-up
1 secondary outcome
Event-free Survival (EFS) for the second time
Time frame: 2 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Results publication: PubMed 34019806Bagaev A, Kotlov N, Nomie K, Svekolkin V, Gafurov A, Isaeva O, Osokin N, Kozlov I, Frenkel F, Gancharova O, Almog N, Tsiper M, Ataullakhanov R, Fowler N. Conserved pan-cancer microenvironment subtypes predict response to immunotherapy. Cancer Cell. 2021 Jun 14;39(6):845-865.e7. doi: 10.1016/j.ccell.2021.04.014. Epub 2021 May 20.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteosarcoma and Transcriptome, 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 3 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: opening soon, as of the sponsor's last update on 24 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lu Musculoskeletal Tumor Center of PKUPH, M.D. (+86-86491437, xielu@pkuph.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event-free Survival (EFS) (time frame: 2 year). 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 NCT06776198, 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 24 Jan 2025.