Cancer Genome Study Using Samples From Patients Treated on Clinical Trial SHR1020-SHR-1210-II-OS

Peking University People's Hospital38 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Osteosarcoma

Interventions

cytology specimenOTHER

Biopsy and Genetic: DNA analysis;Genetic: RNA analysis;Genetic: microarray analysis; Genetic: mutation analysis; Genetic: polymorphism analysis

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of high-grade osteosarcoma * refractory to chemotherapy and intended to receive famitinib and camrelizumab following the protocols of SHR1020-SHR-1210-II-OS * Available tumor tissue samples collected before study drug and after first progression * Must have matching frozen samples of normal tissue and blood Exclusion Criteria: * Patients with concurrent malignancy; patients with prior or concurrent malignancy will be allowed as long as the treating physician considers it unlikely to impact the clinical outcome of the patient * Serious medical illness including but not limited to uncontrolled congestive heart failure, uncontrolled angina, myocardial infarction or cerebrovascular event with 6 months of registration, history of chronic active hepatitis or history of human immunodeficiency virus (HIV) or an active bacterial infection will not be eligible * Pregnant or lactating women

Locations (2)

Peking University People's Hospital

Beijing, Beijing Municipality, China

Peking University Shougang Hospital

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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