Cancer Genome Study Using Samples From Patients Treated on Clinical Trial SHR1020-SHR-1210-II-OS (CSSG-02)
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|ClinicalTrials.gov Identifier: NCT03997747|
Recruitment Status : Recruiting
First Posted : June 25, 2019
Last Update Posted : December 9, 2019
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.
|Condition or disease||Intervention/treatment|
|Osteosarcoma||Other: cytology specimen|
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||40 participants|
|Target Follow-Up Duration:||2 Years|
|Official Title:||A Study to Assess the Therapeutic Efficacy in Advanced Osteosarcoma Patients In the Clinical Trial of SHR1020-SHR-1210-II-OS (Famitinib and Camrelizumab on Chemo-refractory Osteosarcoma) Based on Genomic Analyses of Tumor Specimens|
|Actual Study Start Date :||August 13, 2019|
|Estimated Primary Completion Date :||July 1, 2021|
|Estimated Study Completion Date :||September 1, 2021|
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.
Other: cytology specimen
Biopsy and Genetic: DNA analysis;Genetic: RNA analysis;Genetic: microarray analysis; Genetic: mutation analysis; Genetic: polymorphism analysis
- tumor mutation burden [ Time Frame: 2 years ]NGS analysis, based on total exon sequencing of the specimen. Identification and characterization of tumor mutation burden.
- T cell-inflamed gene expression profile (GEP) [ Time Frame: 2 years ]IFN-g-related mRNA profile
- single nucleotide variants (SNVs) [ Time Frame: 2 years ]NGS analysis, based on total exon sequencing of the specimen
- short insertions and deletions (indels) [ Time Frame: 2 years ]NGS analysis, based on total exon sequencing of the specimen
- copy-number variants (CNVs) [ Time Frame: 2 years ]NGS analysis, based on total exon sequencing of the specimen
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03997747
|Contact: Lu Xie, M.D.||+firstname.lastname@example.org|
|Contact: Jie Xu, M.D.||+email@example.com|
|Peking University People's Hospital||Recruiting|
|Beijing, Beijing, China, 100044|
|Contact: Wei Guo, M.D. +86-10-66583761 firstname.lastname@example.org|
|Contact: Xin Sun, M.D. +86-10-66583761 email@example.com|
|Principal Investigator: Wei Guo, M.D.|
|Peking University Shougang Hospital||Recruiting|
|Beijing, Beijing, China|
|Contact: Lu Xie, M.D. +8613401044719 firstname.lastname@example.org|
|Contact: Jie Xu, M.D. +8615901040835 email@example.com|
|Principal Investigator:||Wei Guo, M.D. and Ph.D.||Musculoskeletal Tumor Center of Peking University People's Hospital|