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| ID | Type | Description | Link |
|---|---|---|---|
| FWA00015357 | Registry Identifier | HHS, Human Protections Administrator | |
| IRB00009424 | Registry Identifier | HHS, IRB | |
| IORG0007849 | Registry Identifier | HHS, IORG | |
| NPI - 1831468511 | Registry Identifier | HHS, Health Care Provider Individual | |
| NPI - 1023387701 | Registry Identifier | HHS, Health Care Provider Organization | |
| IND 178620 | Registry Identifier | FDA IND Commercial |
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The usual approach group, 300 double blind random group separated PC patients currently used the Combined Chemotherapy on ZYTIGA - abiraterone acetate tablet, film coated plus prednisone tablet plus BICALUTAMIDE tablet, it will try to look for the relationship between the Abiraterone therapeutic efficacy and the CYP17 SNP Genotyping, and the relationship between the Abiraterone therapeutic safety and the SULT2A1 SNP Genotyping, based on Oxford precisely sequencing drug targets' genes.
The study approach group, 300 double blind random group separated PC patients currently used the Combined Chemotherapy on China Import - abiraterone acetate tablet plus prednisone tablet plus BICALUTAMIDE tablet, it will try to look for the relationship between the Abiraterone therapeutic efficacy and the CYP17 SNP Genotyping, and the relationship between the Abiraterone therapeutic safety and the SULT2A1 SNP Genotyping, based on Oxford precisely sequencing drug targets' genes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abiraterone - Usual | Experimental |
|
|
| Abiraterone - Study | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abiraterone - Usual | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Measure and Report Abiraterone Drug Targets' SNP Genotypes which are effectiveness-associated, and which are risk-associated. |
| Up to 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Prostate is male organ.
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| Name | Affiliation | Role |
|---|---|---|
| HAN XU, MD/PhD/FAPCR | Medicine Invention Design, Inc. - IORG0007849 - NPI-1023387701 | Study Chair |
| HAN XU, MD/PhD/FAPCR | Medicine Invention Design, Inc. - IORG0007849 - NPI-1023387701 | Study Director |
| HAN XU, MD/PhD/FAPCR | Medicine Invention Design, Inc. - IORG0007849 - NPI-1023387701 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medicine Invention Design, Inc. - IORG0007849 - NPI-1023387701 | Rockville | Maryland | 20853 | United States |
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| Label | URL |
|---|---|
| FWA00015357 | View source |
| IRB00009424 | View source |
| IORG0007849 | View source |
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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 26, 2023 | Aug 28, 2023 | Prot_006.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 26, 2023 | Aug 28, 2023 | SAP_007.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 26, 2023 | Aug 28, 2023 | ICF_008.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D005832 | Genital Diseases, Male |
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| ID | Term |
|---|---|
| D011241 | Prednisone |
| C053541 | bicalutamide |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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No-placebo and random and double blind
| Abiraterone - Study | Drug |
|
|
|
| D000091662 |
| Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |