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出境医 / 临床实验 / Cancer Genome Study Using Samples From Patients Treated on Clinical Trial SHR1020-SHR-1210-II-OS (CSSG-02)
Cancer Genome Study Using Samples From Patients Treated on Clinical Trial SHR1020-SHR-1210-II-OS (CSSG-02)
Study Description
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.
| Condition or disease | Intervention/treatment |
|---|---|
| Osteosarcoma | Other: cytology specimen |
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 Design
| Study Type : | Observational [Patient Registry] |
| Estimated Enrollment : | 40 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| 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 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
|
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
|
Outcome Measures
Primary Outcome Measures :
- 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
Secondary Outcome Measures :
- 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
Tumor samples from patients enrolled on SHR1020-SHR-1210-II-OS before administration of study drug and the first disease progression.
Eligibility Criteria
| Ages Eligible for Study: | 12 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
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.
Criteria
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
Contacts and Locations
Contacts
| Contact: Lu Xie, M.D. | +8613401044719 | xie.lu@hotmail.com | |
| Contact: Jie Xu, M.D. | +8615901040835 | xujie_pkuph@sina.com |
Locations
| China, Beijing | |
| Peking University People's Hospital | Recruiting |
| Beijing, Beijing, China, 100044 | |
| Contact: Wei Guo, M.D. +86-10-66583761 bonetumor@163.com | |
| Contact: Xin Sun, M.D. +86-10-66583761 xinsun1981@hotmail.com | |
| Principal Investigator: Wei Guo, M.D. | |
| Peking University Shougang Hospital | Recruiting |
| Beijing, Beijing, China | |
| Contact: Lu Xie, M.D. +8613401044719 xie.lu@hotmail.com | |
| Contact: Jie Xu, M.D. +8615901040835 xujie_pkuph@sina.com | |
Sponsors and Collaborators
Peking University People's Hospital
Jiangsu HengRui Medicine Co., Ltd.
OrigiMed
Investigators
| Principal Investigator: | Wei Guo, M.D. and Ph.D. | Musculoskeletal Tumor Center of Peking University People's Hospital |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | May 14, 2019 | ||||||||
| First Posted Date | June 25, 2019 | ||||||||
| Last Update Posted Date | December 9, 2019 | ||||||||
| Actual Study Start Date | August 13, 2019 | ||||||||
| Estimated Primary Completion Date | July 1, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
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| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Cancer Genome Study Using Samples From Patients Treated on Clinical Trial SHR1020-SHR-1210-II-OS | ||||||||
| 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 | ||||||||
| 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 Type | Observational [Patient Registry] | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||||||
| Target Follow-Up Duration | 2 Years | ||||||||
| Biospecimen | Retention: Samples With DNA Description:
Tumor samples from patients enrolled on SHR1020-SHR-1210-II-OS before administration of study drug and the first disease progression.
|
||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | 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. | ||||||||
| Condition | Osteosarcoma | ||||||||
| Intervention | Other: cytology specimen
Biopsy and Genetic: DNA analysis;Genetic: RNA analysis;Genetic: microarray analysis; Genetic: mutation analysis; Genetic: polymorphism analysis
|
||||||||
| Study Groups/Cohorts | 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.
Intervention: Other: cytology specimen
|
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| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
40 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | September 1, 2021 | ||||||||
| Estimated Primary Completion Date | July 1, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 12 Years and older (Child, Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| Listed Location Countries | China | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT03997747 | ||||||||
| Other Study ID Numbers | PKUPH-sarcoma 07 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Peking University People's Hospital | ||||||||
| Study Sponsor | Peking University People's Hospital | ||||||||
| Collaborators |
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| Investigators |
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| PRS Account | Peking University People's Hospital | ||||||||
| Verification Date | December 2019 | ||||||||
