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A prospective randomized controlled multicenter clinical study of laser combined with photodynamic therapy in the treatment of high-grade squamous intraepithelial lesions of the cervix

A prospective randomized controlled multicenter clinical study of laser combined with photodynamic therapy in the treatment of high-grade squamous intraepithelial lesions of the cervix

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100053657
Enrollment
Unknown
Registered
2021-11-26
Start date
2022-01-01
Completion date
Unknown
Last updated
2025-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical high-grade epithelial lesions HSIL combined with high-risk HPV infection

Interventions

Photodynamic therapy + CO2 laser therapy group:6 times Photodynamic therapy + 1 time CO2 laser therapy
Photodynamic therapy group:6 times Photodynamic therapy

Sponsors

Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Female, Aged 18-45 years; 2. High-risk HPV positive; 3. HSIL (CIN2 and p16+) or HSIL (CIN2, 3 ungraded): within 3 months cervical histopathological examination was CIN2 and immunohistochemical p16 positive, or HSIL (CIN2, 3 ungraded); 4. The squamocolumnar junction is completely visible under colposcopy, the lesions are completely visible, and there is no CIN2+ in the cervical canal scraping pathology; 5. The pregnancy test is negative, and condoms are used for contraception from the end of the last menstrual period to 3 months after the start of the test, or when they agree to have sex; 6. Have the desire to preserve the structure and/or function of the cervix, voluntarily participate and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Colposcopy cannot rule out the possibility of invasive cancer, or the lesions extend to the vaginal wall; 2. Severe pelvic inflammation, cervical inflammation or other serious gynecological inflammation was found in clinical examination; 3. Those with undiagnosed vaginal bleeding; 4. Those who currently suffer from allergic diseases; those who are suspected or known to suffer from porphyria or known to have a history of allergy to the experimental drugs and their chemical structures similar to drugs; 5. Patients with severe cardiovascular and cerebrovascular, neurological, mental, endocrine, liver function, hematopoietic system diseases; known to be severely weakened in immune function, or who need long-term use of glucocorticoids and immunosuppressants; patients with malignant tumors; 6. Lactating women; 7. Those who have taken physical therapy or surgical treatment after the pathological diagnosis of HSIL; 8. Those who have received interferon and antiviral drugs within 3 months; 9. Those with poor compliance, or those who are expected to be unable to complete the test and follow-up due to restrictions on residence and other conditions; 10. In addition to the above, the investigator judges that they are not suitable to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
human papillomavirus;

Secondary

MeasureTime frame
Cervical cytology;Colposcopy + pathological biopsy;

Countries

China

Contacts

Public ContactQiu Lihua

Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine

lilyqiulh@126.com+86 13801946776

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026