An observational study in Osteosarcoma, sponsored by Peking University People's Hospital. Completed at 2 sites in China. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2022-06-03.
Sponsored by Peking University People's Hospital · Observational
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.
446 studies on the registry are indexed under Osteosarcoma; 117 are open to participants now.
This study's enrollment of 38 is below the median of 100 across 91 observational studies indexed under Osteosarcoma.
Browse Osteosarcoma studies →Peking University People's Hospital is the lead sponsor of 603 studies on the registry; 241 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Other: cytology specimen
Biopsy and Genetic: DNA analysis;Genetic: RNA analysis;Genetic: microarray analysis; Genetic: mutation analysis; Genetic: polymorphism analysis
tumor mutation burden
NGS analysis, based on total exon sequencing of the specimen. Identification and characterization of tumor mutation burden.
Time frame: 2 years
T cell-inflamed gene expression profile (GEP)
IFN-g-related mRNA profile
Time frame: 2 years
single nucleotide variants (SNVs)
NGS analysis, based on total exon sequencing of the specimen
Time frame: 2 years
short insertions and deletions (indels)
NGS analysis, based on total exon sequencing of the specimen
Time frame: 2 years
copy-number variants (CNVs)
NGS analysis, based on total exon sequencing of the specimen
Time frame: 2 years
Plan to share: No
No publications or documents are linked to this record.
Ran from Aug 2019 to primary completion in Oct 2021, 25 months.
Of 36 observational studies under Osteosarcoma, half reached primary completion within 75 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 105. This study's 25 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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