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| ID | Type | Description | Link |
|---|---|---|---|
| 2022YFB3604704 | Other Grant/Funding Number | Ministry of Science and Technology of the People's Republic of China |
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To investigate the efficacy and safety of photodynamic therapy (20% 5-amino-ketovalerate 630nm red light) in the treatment of cervical and vaginal intraepithelial neoplasia in women in the real world.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALA-PDT | Other | Patients choose PDT to treat the disease |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALA-PDT | Procedure | use ALA_PDT to treat the disease |
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| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of the treatment | colposcopy and biopsy will be performed one month after the treatment. Patients will be categorised as having complete remission(CR) if biopsy confirmed LSIL. If CIN 2/VAIN 2 was found after the first course of PDT, it would be categorised as partial remission(PR) if they are CIN3/VAIN3 before treatment. Those with the same grade were categorised as persistent disease(PD). The proportion of CR and PR after PDT treatment. | 1 month after the treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qin Han | Contact | 13810632686 | Lmlfe_lyn@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Unniversity Third Hospital | Recruiting | Beijing | Beijing Municipality | 100191 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 1, 2023 | May 8, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 1, 2023 | May 8, 2025 | ICF_001.pdf |
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