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| Name | Class |
|---|---|
| The First Affiliated Hospital of Guangzhou Medical University | OTHER |
| Sun Yat-sen University | OTHER |
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This study prospectively evaluates whether the use of iCAGES (integrated CAncer GEnome Score) tool in guiding the treatment of advanced cancers is superior to current standard care or IHC-guided therapy in progress free survival (PFS),overall survival (OS),and improvement of life quality.
Cancer is a fatal disease caused by the accumulation of various oncogene and tumor suppressor gene mutations. Studies of high-throughput sequencing for patients who suffered from cancer has found that different mutations play a different role in the occurrence and development of different cancers. Several gene panels already exist to help identify mutations in a few genes that may have corresponding FDA-approved drugs or drugs under clinical trials. However, given whole-genome/exome sequencing data, the suitable clinical analysis tool to analyze individualized cancer-related gene mutations, and recommend the most appropriate targeted treatment options among hundreds of possible drugs therapy is absent currently.
The recently proposed iCAGES is a precise biomedical informatics analysis tool, which could help increase the accuracy of cancer driver gene detection and prioritization, bridge the gap between personal cancer genomic data and prior cancer research knowledge,and facilitate cancer molecular diagnosis as well as personalized precision therapy.
IHC detection of multiple molecules such as EGFR, HER2-3, TROP3, NECTIN4, MET, B7-H3-4, B1-H7, Claudin18.2, FGFR1-4, Mesothelin, ROR1, BCMA, AXL, TF, FRα, CD70, PPARα, HIF-2α, RET, ROS1, NTRK, CDK4/6, FLT3, EZH2 are also scheduled for appropriate targeted therapy and comparison if available.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group (A group) | In this group, we perform whole exome or genome sequencing of tumor sample in compared to blood sample, screen tumor-related special mutations by using biomedical informatics analysis procedure and utilized the iCAGES system to rank the most appropriate drugs available and then manually examine this list to select the best therapeutic strategy for the patient based on availability of drug and expert knowledge. The PFS, OS, and quality of life (QOL) will be recorded and compared with that from standard care. |
| |
| Control group (B group) | In this group, patients with advanced cancers (matched with Group A) will be treated under the guidance of NCCN, without performing iCAGES analysis. | ||
| Control group (C group) | In this group, patients with advanced cancers (matched with Group A) will be treated with appropriate targeted drugs according to IHC detection of more than 20 protein molecules with blank tissue slides from the cancer. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| inhibitors, ADC drugs such as tarceva, capmatinib, padcev et al for A/C group. | Drug | Choose appropriate targeted drugs according to NGS/IHC results. |
|
| Measure | Description | Time Frame |
|---|---|---|
| PFS | The PFS will be recorded during the follow up time. | 2 years |
| OS | The OS will be recorded during the follow up time. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life. | Physicians Global Assessment to measure quality of life | 2 years |
| Pain | Visual Analog Score for pain | one year |
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Inclusion Criteria:
Exclusion Criteria:
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In this study, all the patients will be recruited from the Second Affiliated Hospital of Guangzhou Medical University and the collaborated Hospitals during 01/07/2017 to 01/07/2019, 250 advanced patients (90 cases for A group, 70 cases for B group, and 90 cases for C group) are anticipated to be collected. All the patients are more than 18 years old and less than 75 years old. The follow-up will be performed every 2 month until 2 years after the first treatment post-recruitment or quit.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhenfeng Zhang, MD,PhD | Contact | +86-020-34153532 | zhangzhf@gzhmu.edu.cn | |
| Deji Chen, MD,PhD | Contact | +86-020-34153532 | chendeji2003@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhenfeng Zhang, MD,PhD | Second Affiliated Hospital of Guangzhou Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Guangzhou Medical University | Recruiting | Guangzhou | Guangdong | 510260 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28007024 | Background | Dong C, Guo Y, Yang H, He Z, Liu X, Wang K. iCAGES: integrated CAncer GEnome Score for comprehensively prioritizing driver genes in personal cancer genomes. Genome Med. 2016 Dec 22;8(1):135. doi: 10.1186/s13073-016-0390-0. |
| Label | URL |
|---|---|
| test link | View source |
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cancer biopsy samples
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000069347 | Erlotinib Hydrochloride |
| C000613976 | capmatinib |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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