Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Jiangsu HengRui Medicine Co., Ltd. | INDUSTRY |
| OrigiMed | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
RATIONALE: Studying samples of tumor tissue from patients with advanced osteosarcoma refractory to chemotherapy in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to osteosarcma treatment combining anti-angiogenesis tyrosine kinase inhibitors and anti-PD-1 antibody.
PURPOSE: This research study is looking at the cancer genome using tumor samples from patients with advanced stage osteosarcoma treated on clinical trial SHR1020-SHR-1210-II-OS.
OBJECTIVES:
To investigate the clinical relevance of conducting comprehensive molecular analyses on clinically annotated high-quality tumor specimens from patients with advanced stage osteosarcoma.
OUTLINE: This is a single-center study.
Biological specimens are collected from participating clinical site and analyzed by transcription profiling of RNA and microRNA; detection of DNA copy number changes and chromosomal rearrangements; epigenetic modifications analyses; and sequencing of genomic segments, genes, and regulatory regions to assess sequence variation. Clinical information associated with each specimen donor is also collected.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| comprehensive genomic analysis group | Patients undergo collection of tissue samples for genomic analysis via mass spectrometry, PCR, and microarray. The therapy patients received would not be based on the results of the genomic analysis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cytology specimen | Other | Biopsy and Genetic: DNA analysis;Genetic: RNA analysis;Genetic: microarray analysis; Genetic: mutation analysis; Genetic: polymorphism analysis |
|
| Measure | Description | Time Frame |
|---|---|---|
| tumor mutation burden | NGS analysis, based on total exon sequencing of the specimen. Identification and characterization of tumor mutation burden. | 2 years |
| T cell-inflamed gene expression profile (GEP) | IFN-g-related mRNA profile | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| single nucleotide variants (SNVs) | NGS analysis, based on total exon sequencing of the specimen | 2 years |
| short insertions and deletions (indels) | NGS analysis, based on total exon sequencing of the specimen |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
All patients have histologically proven metastatic or locally advanced osteosarcoma, reviewed by the Pathology Committee of Peking University People's Hospital, and are not amenable to curative-intent surgery. Previous systemic chemotherapy had failed to prevent the exacerbation of disease, including high-dose methotrexate (HD-MTX), doxorubicin (ADM), cisplatin (DDP) with/without ifosfamide (IFO). Tumors have to be measurable with computed tomography scan or magnetic resonance imaging, per RECIST, version 1.1. Patients undergo collection of tissue samples for genomic analysis via mass spectrometry, PCR, and microarray.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Wei Guo, M.D. and Ph.D. | Musculoskeletal Tumor Center of Peking University People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Beijing | Beijing Municipality | 100044 | China | ||
| Peking University Shougang Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012516 | Osteosarcoma |
| ID | Term |
|---|---|
| D018213 | Neoplasms, Bone Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
Not provided
Not provided
Not provided
Tumor samples from patients enrolled on SHR1020-SHR-1210-II-OS before administration of study drug and the first disease progression.
| 2 years |
| copy-number variants (CNVs) | NGS analysis, based on total exon sequencing of the specimen | 2 years |
| Beijing |
| Beijing Municipality |
| China |
| D009369 | Neoplasms |
| D012509 | Sarcoma |