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| ID | Type | Description | Link |
|---|---|---|---|
| FWA00015357 | Registry Identifier | HHS, Human Protections Administrator | |
| NPI - 1831468511 | Registry Identifier | HHS, Health Care Provider Individual | |
| NPI - 1023387701 | Registry Identifier | HHS, Health Care Provider Organization | |
| IRB00009424 | Registry Identifier | HHS, IRB | |
| IORG0007849 | Registry Identifier | HHS, IORG | |
| IND 178172 | Registry Identifier | FDA IND |
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| Name | Class |
|---|---|
| UnitedHealthcare | OTHER |
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Explore the relationship between drug target topoisomerase II gene single nucleotide polymorphisms and Etoposide (VP-16) therapeutic-effects in patients with small cell lung cancer, based on Oxford precisely sequencing drug targets' genes.
Explore the relationship between drug target CYP4503A4 gene single nucleotide polymorphisms and Etoposide (VP-16) side-effects in patients with small cell lung cancer, based on Oxford precisely sequencing drug targets' genes.
The usual approach group, after lung tissue biopsy, 300 double blind random group separated SCLC patients currently used the Chemotherapy on ETOPOSIDE capsule, it will try to look for the relationship between the ETOPOSIDE therapeutic efficacy and the Topoisomerase II SNP Genotyping, and the relationship between the ETOPOSIDE therapeutic safety and the CYP4503A4 SNP Genotyping, based on Oxford precisely sequencing drug targets' genes.
The study approach group, after lung tissue biopsy, 300 double blind random group separated SCLC patients currently used the Chemotherapy on China Import Etoposide Capsule, it will try to look for the relationship between the ETOPOSIDE therapeutic efficacy and the Topoisomerase II SNP Genotyping, and the relationship between the ETOPOSIDE therapeutic safety and the CYP4503A4 SNP Genotyping, based on Oxford precisely sequencing drug targets' genes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ETOPOSIDE - Usual | Experimental |
|
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| ETOPOSIDE - Study | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ETOPOSIDE - Usual | Drug | Etoposide Capsule |
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| Measure | Description | Time Frame |
|---|---|---|
| Find Etoposide Drug Targets' SNP Genotypes which are effectiveness-associated, and which are risk-associated. |
| Duration at least 90 days |
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The inclusion criteria:
The exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| HAN XU, MD/PhD/FAPCR | Medicine Invention Design, Inc. (MIDI) - IORG0007849 - NPI 1023387701 | Principal Investigator |
| HAN XU, MD/PhD/FAPCR | Medicine Invention Design, Inc. (MIDI) - IORG0007849 - NPI 1023387701 | Study Director |
| HAN XU, MD/PhD/FAPCR | Medicine Invention Design, Inc. (MIDI) - IORG0007849 - NPI 1023387701 | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medicine Invention Design, Inc. (MIDI) - IORG0007849 - NPI 1023387701 | Rockville | Maryland | 20853 | United States |
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| Label | URL |
|---|---|
| FWA \< 00015357 \> \< Medicine Invention Design Incorporation (MIDI) \> | View source |
| IRB \< 00009424 \> \< Medicine Invention Design Incorporation (MIDI) \> | View source |
| IORG \< 0007849 \> \< Medicine Invention Design Incorporation (MIDI) \> |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 16, 2025 | Jul 18, 2025 | Prot_019.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 16, 2025 | Jul 18, 2025 | SAP_020.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 16, 2025 | Jul 18, 2025 | ICF_021.pdf |
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| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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No-placebo and random and double blind
| ETOPOSIDE - Study | Drug | China Import Etoposide Capsule |
|
|
| View source |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |