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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 | |
| IND178174 | Registry Identifier | FDA, IND |
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| Name | Class |
|---|---|
| UnitedHealthcare | OTHER |
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Explore the relationship between drug target topoisomerase I gene single nucleotide polymorphisms and Topotecan 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 Topotecan 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 Topotecan capsule, it will try to look for the relationship between the Topotecan therapeutic efficacy and the Topoisomerase I SNP Genotyping, and the relationship between the Topotecan 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 Topotecan Capsule, it will try to look for the relationship between the Topotecan therapeutic efficacy and the Topoisomerase I SNP Genotyping, and the relationship between the Topotecan therapeutic safety and the CYP4503A4 SNP Genotyping, based on Oxford precisely sequencing drug targets' genes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topotecan - usual | Experimental |
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| Topotecan - study | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topotecan - usual | Drug | Topotecan Capsule |
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| Measure | Description | Time Frame |
|---|---|---|
| Find Topotecan Drug Targets' SNP Genotypes which are effectiveness-associated, and which are risk-associated. |
| Duration up to 14 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| HAN XU, MD/PhD/FAPCR | Medicine Invention Design, Inc. - IRB00009424 - IORG0007849 | Study Chair |
| HAN XU, MD/PhD/FAPCR | Medicine Invention Design, Inc. - IORG0007849 - NPI-1023387701 | Study Director |
| HAN ID XU, MD/PhD/FAPCR | Medicine Invention Design, Inc. - IORG0007849 - NPI-1023387701 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medicine Invention Design Incorporation | 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 | Aug 25, 2025 | Aug 29, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 25, 2025 | Aug 29, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 25, 2025 | Aug 29, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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No-placebo and random and double blind
| Topotecan - study | Drug | China Import Topotecan Capsule |
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| View source |