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| ID | Type | Description | Link |
|---|---|---|---|
| FWA00015357 | Registry Identifier | HHS, Human Protections Administrator | |
| IORG0007849 | Registry Identifier | HHS, IORG | |
| IRB00009424 | Registry Identifier | HHS, IRB | |
| NPI-1831468511 | Registry Identifier | HHS, Health Care Provider Individual | |
| NPI-1023387701 | Registry Identifier | HHS, Health Care Provider Organization | |
| IND 009549 | Registry Identifier | FDA, Investigational New Drug Application (IND) |
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| Name | Class |
|---|---|
| UnitedHealthcare | OTHER |
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Conducting an early phase clinical trial to assess CEA Antigen Presentation Therapeutic Biological Product Mix activity that suggests the potential for clinical benefit of CEA positive rectal cancer patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Assess for CEA Antigen Presentation Therapeutic Biological Product Mix activity | Experimental | CEA protein antigen 0.05 mg add into BCG Organism 50 MG |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CEA protein antigen plus BCG Vaccine Mix for percutaneous use | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| 20 Rectal Cancer Participants with CEA blood test | Positive testing CEA by blood-drawing | Duration up to 90 days |
| 20 Rectal Cancer Participants with IGRA blood test with CEA protein antigen | Positive IGRA blood test with CEA protein antigen after percutaneous use 21 days | Duration up to 90 days |
| 20 Rectal Cancer Participants with IGRA blood test with TB antigens |
| Duration up to 90 days |
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Conducting an early phase clinical trial to assess CEA Antigen Presentation Therapeutic Biological Product Mix that suggests the potential for clinical benefit of CEA positive rectal cancer patients.
20 CEA Positive Rectal Cancer Patients
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| HAN XU, MD/PhD/FAPCR | IRB00009424--NPI-1831468511 | Study Chair |
| HAN XU, MD/PhD/FAPCR | IORG0007849--NPI-1023387701 | Study Director |
| HAN XU, MD/PhD/FAPCR | IORG0007849--FWA00015357 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medicine Invention Design, Inc. (MIDI) - c/o - IORG0007849 - NPI-1023387701 | Rockville | Maryland | 20853 | United States |
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| Label | URL |
|---|---|
| IORG0007849 | View source |
| IRB00009424 | View source |
| FWA00015357 |
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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 27, 2024 | Aug 29, 2024 |
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Open Label
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|
| Prot_014.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 27, 2024 | Aug 29, 2024 | SAP_015.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 27, 2024 | Aug 29, 2024 | ICF_016.pdf |
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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