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

Completed

• Conditions: Osteosarcoma
• Interventions: Other: cytology specimen

• Registration Number: NCT03997747
• Lead Sponsor: Peking University People's Hospital

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2019-05-14
• Study First Submitted QC: 2019-06-23
• Study First Posted: 2019-06-25
• Study Start: 2019-08-13
• Primary Completion: 2021-10-01
• Study Completion: 2021-12-01
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-01
• Last Update Posted: 2022-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
comprehensive genomic analysis group	cytology specimen	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.

Primary Outcome Measures

Name	Time	Method
T cell-inflamed gene expression profile (GEP)	2 years	IFN-g-related mRNA profile
tumor mutation burden	2 years	NGS analysis, based on total exon sequencing of the specimen. Identification and characterization of tumor mutation burden.

Secondary Outcome Measures

Name	Time	Method
single nucleotide variants (SNVs)	2 years	NGS analysis, based on total exon sequencing of the specimen
short insertions and deletions (indels)	2 years	NGS analysis, based on total exon sequencing of the specimen
copy-number variants (CNVs)	2 years	NGS analysis, based on total exon sequencing of the specimen

Trial Locations

Locations (2)

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China

Peking University Shougang Hospital; 🇨🇳 Beijing, Beijing, China