RecruitingNot Applicable

Comparison of 5-ALA Photodynamic Therapy and CO2 Laser for Treating Persistent Low-Grade Cervical Lesions With High-Risk HPV Infection

China40 participantsStarted 2023-09-11

Plain-language summary

Non-RCT clinical trial comparing 5-ALA photodynamic therapy and CO2 laser for persistent high-risk HPV-related low-grade cervical lesions.

Age range18 Years – 65 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Aged 18-65 years old with a history of sexual activity.
✓. Subclinical infected individuals who have been confirmed as HR-HPV positive (if there is the same positive type in the typing test) for more than 1 year using HPV typing test, HPV E6/E7 mRNA test, HPV DNA test, and cervical triple step diagnostic procedure (cytology colposcopy histopathology).
✓. Patients diagnosed with LSIL by pathological examination of cervical biopsy under colposcopy with an interval of more than 1 year.
✓. No fundamental diseases of important organs.
✓. Agree to receive treatment and/or follow-up according to regulations and sign an informed consent form.
✓. There has been no history of using other drugs related to HPV infection in the past 3 months.

✕. HR-HPV persistent infection.
✕. A total hysterectomy has been performed.
✕. Concomitant endometrial cancer, ovarian cancer, and other reproductive tract tumors.
✕. Complicated with abnormal heart, liver, and kidney functions, immune dysfunction, or immune system diseases such as systemic lupus erythematosus (SLE).
✕. Using drugs such as immunosuppressants, antiviral agents, and glucocorticoids.
✕

Regression of Cervical Lesions.

Timeframe: Assessed at 6 months after the last PDT session.

NCT IDNCT06052033

SponsorFirst Affiliated Hospital of Wenzhou Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-08-10

YAN HU, PHD

Who can participate

Age range18 Years – 65 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Aged 18-65 years old with a history of sexual activity.
✓. Subclinical infected individuals who have been confirmed as HR-HPV positive (if there is the same positive type in the typing test) for more than 1 year using HPV typing test, HPV E6/E7 mRNA test, HPV DNA test, and cervical triple step diagnostic procedure (cytology colposcopy histopathology).
✓. Patients diagnosed with LSIL by pathological examination of cervical biopsy under colposcopy with an interval of more than 1 year.
✓. No fundamental diseases of important organs.
✓. Agree to receive treatment and/or follow-up according to regulations and sign an informed consent form.
✓. There has been no history of using other drugs related to HPV infection in the past 3 months.

✕. HR-HPV persistent infection.
✕. A total hysterectomy has been performed.
✕. Concomitant endometrial cancer, ovarian cancer, and other reproductive tract tumors.
✕. Complicated with abnormal heart, liver, and kidney functions, immune dysfunction, or immune system diseases such as systemic lupus erythematosus (SLE).
✕. Using drugs such as immunosuppressants, antiviral agents, and glucocorticoids.
✕