Cancer Genome Study Using Samples From Patients Treated on Clinical Trial SHR1020-SHR-1210-II-OS (CSSG-02)

Peking University

Status: Completed

Conditions: Osteosarcoma

Treatments: Other: cytology specimen

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03997747

PKUPH-sarcoma 07

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

38 participants in 1 patient group

comprehensive genomic analysis group

Description:

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.

Treatment:

Other: cytology specimen