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Multicenter Prospective Non-randomized Controlled Study of Ella Photodynamic Therapy for Cervical HSIL/CIN2

NCT ID: NCT07306260

Last Updated: 2025-12-29

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

560 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2027-12-31

Brief Summary

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This study evaluates the efficacy and safety of ALA-PDT versus LEEP in treating cervical HSIL/CIN2, aiming to demonstrate non-inferiority in clinical efficacy.

Detailed Description

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This study aims to conduct a multicenter, prospective, concurrent non-controlled clinical trial to evaluate the clinical efficacy of 5-aminolevulinic acid photodynamic therapy (ALA-PDT) compared with loop electrosurgical excision procedure (LEEP) in patients with high-grade squamous intraepithelial lesion (HSIL/CIN2), using a non-inferiority design. The primary objective is to demonstrate that ALA-PDT is non-inferior to LEEP with respect to key efficacy endpoints. Furthermore, the safety profiles, cervical tissue regeneration outcomes, and long-term prognoses of both treatment modalities will be comprehensively assessed. The results are anticipated to provide robust clinical evidence supporting ALA-PDT as a safer, less invasive, and function-preserving alternative for the management of HSIL/CIN2.

Conditions

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HSIL, High Grade Squamous Intraepithelial Lesion CIN 2 HPV (Human Papillomavirus)-Associated Photodynamic Therapy (PDT)

Keywords

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photodynamic therapy High Grade Squamous Intraepithelial Lesion human papillomavirus loop electrosurgical excision procedure efficacy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ALA-PDT Group

ALA-PDT treatment for cervical lesions 6 to 9 times

Group Type EXPERIMENTAL

ALA-PDT

Intervention Type PROCEDURE

Apply 20% ALA gel for 3 hours, followed by red light irradiation, repeated every 7-14 days for a total of 6-9 sessions.

LEEP Group

LEEP surgery for cervical lesions

Group Type ACTIVE_COMPARATOR

LEEP surgery

Intervention Type PROCEDURE

After anesthesia, cervical iodine staining was performed, followed by LEEP.

Interventions

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ALA-PDT

Apply 20% ALA gel for 3 hours, followed by red light irradiation, repeated every 7-14 days for a total of 6-9 sessions.

Intervention Type PROCEDURE

LEEP surgery

After anesthesia, cervical iodine staining was performed, followed by LEEP.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Female, 25-60 years, understands study procedures and consents to participate;
2. Colposcopy-guided cervical biopsy within 3 months showing HSIL/CIN2;
3. Provides written informed consent.

Exclusion Criteria

1. Cytology showing ASC-H, HSIL, AGC, or AIS; or evidence of malignant cells on cytology/histology, or suspicion of malignancy or invasive cancer;
2. Colposcopy findings suggestive of invasive cancer or lesion extension to the vaginal wall;
3. Severe pelvic, cervical, or other gynecological inflammatory conditions identified clinically;
4. Undiagnosed vaginal bleeding;
5. Active allergic disease, porphyria, or history of allergy to the study drug or structurally similar agents;
6. Severe cardiovascular, neurological, psychiatric, endocrine, hepatic, or hematologic disorders; known immunodeficiency; long-term glucocorticoid or immunosuppressant use; active autoimmune disease; or other malignancies;
7. Pregnant or breastfeeding women;
8. History of hysterectomy, cervical cancer treatment, or cervical excision/ablation within 6 months (e.g., conization, LEEP, laser);
9. Use of interferon or antiviral therapy within 3 months;
10. Any other condition deemed unsuitable for participation by the investigator.
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Women's Hospital School Of Medicine Zhejiang University

OTHER

Sponsor Role collaborator

First People's Hospital of Hangzhou

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Ningbo University

NETWORK

Sponsor Role collaborator

Shaoxing People's Hospital

OTHER

Sponsor Role collaborator

Linping First People's Hospital

UNKNOWN

Sponsor Role collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Women's Hospital School Of Medicine Zhejiang University

Hangzhou, Zhejiang, China

Site Status

First People's Hospital of Hangzhou

Hangzhou, Zhejiang, China

Site Status

Hangzhou Linping District first People's Hospital

Hangzhou, Zhejiang, China

Site Status

First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, China

Site Status

Shaoxing People's Hospital

Shaoxing, Zhejiang, China

Site Status

Countries

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China

Central Contacts

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Xiaoyun Wang, Doctor

Role: CONTACT

Phone: 15168479997

Email: [email protected]

Facility Contacts

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Ying Li

Role: primary

Hongkai Shang, Doctor

Role: primary

Lifang You

Role: primary

Role: backup

Juanjuan Shi

Role: primary

Huaqin Pang

Role: primary

Role: backup

Other Identifiers

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2025-1382

Identifier Type: -

Identifier Source: org_study_id