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

ConditionsHSIL, High Grade Squamous Intraepithelial LesionCIN 2HPV (Human Papillomavirus)-AssociatedPhotodynamic Therapy (PDT)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age25-65
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Female, 25-60 years, understands study procedures and consents to participate;

Colposcopy-guided cervical biopsy within 3 months showing HSIL/CIN2;

Provides written informed consent.

Disqualifiers

Cytology showing ASC-H, HSIL, AGC, or AIS; or evidence of malignant cells on cytology/histology, or suspicion of malignancy or invasive cancer;

Colposcopy findings suggestive of invasive cancer or lesion extension to the vaginal wall;

Severe pelvic, cervical, or other gynecological inflammatory conditions identified clinically;

Undiagnosed vaginal bleeding;

Trial design

Design model

Parallel

Treatments tested in this trial

  • ALA-PDT

    Procedure/Surgery

    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 surgery

    Procedure/Surgery

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

Treatment groups

560 Participants
are divided into 2 treatment groups
Group A: ALA-PDT GroupExperimental treatment 1 intervention
Group B: LEEP GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Lesion effective rate

Proportion of patients with LSIL or normal histopathology on colposcopy-guided cervical biopsy, assessed at 6 months post-treatment as the primary endpoint.

Time frame
6 months

Secondary outcomes

1

Lesion effective rate

Proportion of patients with LSIL or normal histopathology on colposcopy-guided cervical biopsy, assessed at 12 and 24 months post-treatment.

Time frame
2 years
2

HPV clearance rate

HPV clearance rates at 3, 6, 9, 12, and 24 months post-treatment

Time frame
2 years
3

Lesion cure rate

Proportion of patients with normal colposcopy-guided cervical biopsy results and negative HPV

Time frame
2 years

Other outcomes

1

Impact on cervical anatomy and function

Cervical length and function before and after treatment, and subsequent pregnancy outcomes in patients desiring fertility.

Time frame
2 years
2

Adverse events

Record post-treatment adverse events including bleeding, infection, and pain.

Time frame
2 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Second Affiliated Hospital, School of Medicine, Zhejiang University

Lead sponsor

Women's Hospital School Of Medicine Zhejiang University

Collaborator

First People's Hospital of Hangzhou

Collaborator

First Affiliated Hospital of Ningbo University

Collaborator

Shaoxing People's Hospital

Collaborator

Linping First People's Hospital

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: