Efficacy and Safety of Photodynamic Therapy for Cervical and Vaginal Intraepithelial Neoplasia

NCT ID: NCT06982976

Last Updated: 2025-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-28

Study Completion Date

2028-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Precancerous Cervical Lesion

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ALA-PDT

Patients choose PDT to treat the disease

Group Type OTHER

ALA-PDT

Intervention Type PROCEDURE

use ALA\_PDT to treat the disease

Interventions

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ALA-PDT

use ALA\_PDT to treat the disease

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* cervical/vaginal high-grade squamous intraepithelial lesions (HSILs) confirmed by colposcopy and pathological biopsy (CIN2 /CIN3 and/or VaIN2/ VaIN3) or persistent CIN1/VaIN1 lasting for more than one year with a strong willingness to treat;
* colposcopy was adequate, and analysable colposcopy images were retained;
* endocervical curettage (ECC) did not suggest higher-grade lesions.

Exclusion Criteria

* coexistence or suspicion of cancer;
* porphyria or suspected allergies to red and blue light;
* severe medical comorbidities;
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Peking University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Peking Unniversity Third Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Qin Han

Role: CONTACT

13810632686

Facility Contacts

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Qin Han

Role: primary

13810632686

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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2022YFB3604704

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB00006761-M2023505

Identifier Type: -

Identifier Source: org_study_id

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