Skip to content

Optimization of surgical procedures and technological innovation to reduce uterine injury \u sub study 2: a multicenter clinical study of systemic photodynamic therapy for high-grade cervical lesions

Optimization of surgical procedures and technological innovation to reduce uterine injury \u sub study 2: a multicenter clinical study of systemic photodynamic therapy for high-grade cervical lesions

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500102685
Enrollment
Unknown
Registered
2025-05-19
Start date
2025-05-20
Completion date
Unknown
Last updated
2025-05-26

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

Conditions

Patients with cervical high-grade squamous intraepithelial lesion grade III (CIN3)

Interventions

Photodynamic group:NA
Surgery group:NA

Sponsors

Peking University Shenzhen Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1.Photodynamic therapy group: (1) women aged 18-40 years with childbearing requirements, non pregnant and in good general condition; (2) Pathological diagnosis of cervical high-grade squamous intraepithelial lesion grade III (CIN3) patients, requiring systemic photodynamic therapy; (3) Signed informed consent. 2.The traditional surgical treatment group: (1) women aged 18-40 years with childbearing requirements, non pregnant and in good general condition; (2) Pathological diagnosis of cervical high-grade squamous intraepithelial lesion grade III (CIN3) patients; (3) Signed informed consent.

Exclusion criteria

Exclusion criteria: 1.Photodynamic therapy group: (1) patients with porphyria and other diseases worsened by light or allergic to porphyrins or any excipients; (2) Pregnancy and lactation; (3) Suffering from immune system diseases and using immunosuppressive or regulatory drugs (such as corticosteroids may reduce the efficacy of PDT); (4) Acute inflammatory stage and general infectious disease active stage; (5) Antithrombotic or antiplatelet agglutination drugs are being used in large doses; (6) Patients with obvious abnormal liver function, coagulation dysfunction and other serious uncontrolled medical comorbidities. (7) Those who have serious mental abnormalities and cannot cooperate; (8) The investigator considered it inappropriate to participate in this study; (9) The researcher, research assistant, research pharmacist, clinical research assistant or other personnel involved in this study. 2.The traditional surgical treatment group: (1) patients with porphyria and other diseases worsened by light or allergic to porphyrins or any excipients; (2) Pregnancy and lactation; (3) Suffering from immune system diseases and using immunosuppressive or regulatory drugs (such as corticosteroids may reduce the efficacy of PDT); (4) Acute inflammatory stage and general infectious disease active stage; (5) Antithrombotic or antiplatelet agglutination drugs are being used in large doses; (6) Patients with obvious abnormal liver function, coagulation dysfunction and other serious uncontrolled medical comorbidities. (7) Those who have serious mental abnormalities and cannot cooperate; (8) The investigator considered it inappropriate to participate in this study; (9) The researcher, research assistant, research pharmacist, clinical research assistant or other personnel involved in this study.

Design outcomes

Primary

MeasureTime frame
Lesion outcome;Pregnancy rate;Preterm birth rate;Abortion rate;

Secondary

MeasureTime frame
HPV negative conversion rate;

Countries

China

Contacts

Public ContactChangzhong Li

Peking University Shenzhen Hospital

15168888909@163.com+86 15168888909

Outcome results

None listed

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