Using light therapy to treat precancerous cervical and vaginal lesions
Efficacy and Safety of Photodynamic Therapy for Cervical and Vaginal Intraepithelial Neoplasia:A Multicenter Prospective Cohort Study
This study is testing if light therapy can safely treat precancerous cervical and vaginal lesions in women with specific types of abnormal cells.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Female |
| Sponsor | Peking University Third Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06982976 on ClinicalTrials.gov |
What this trial studies
This study investigates the efficacy and safety of photodynamic therapy using 20% 5-amino-ketovalerate and 630nm red light for treating cervical and vaginal intraepithelial neoplasia in women. The approach focuses on patients with confirmed high-grade squamous intraepithelial lesions or persistent low-grade lesions who are willing to undergo treatment. The study aims to gather real-world data on the treatment's effectiveness and safety profile.
Who should consider this trial
Good fit: Ideal candidates for this study are women diagnosed with high-grade squamous intraepithelial lesions or persistent low-grade lesions who are willing to receive treatment.
Not a fit: Patients with confirmed cancer, severe medical comorbidities, or allergies to light therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a non-invasive option for women with precancerous cervical and vaginal lesions, potentially reducing the need for more invasive procedures.
How similar studies have performed: While photodynamic therapy has been explored in various contexts, this specific application for cervical and vaginal intraepithelial neoplasia is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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；
Where this trial is running
Beijing, Beijing Municipality
- Peking Unniversity Third Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Qin Han
- Email: Lmlfe_lyn@126.com
- Phone: 13810632686
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.