ALA-PDT vs LEEP for cervical HSIL/CIN2: a multicenter non-randomized comparison

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter prospective study comparing 5-aminolevulinic acid photodynamic therapy (ALA-PDT) with loop electrosurgical excision procedure (LEEP) for cervical HSIL/CIN2. The design is non-randomized and aims to show that ALA-PDT is not inferior to LEEP in key efficacy outcomes while also evaluating safety, cervical tissue regeneration, and long-term prognosis. Participants are women aged 25-60 with biopsy-confirmed HSIL/CIN2, undergoing either ALA-PDT or LEEP. The study will collect data on treatment performance, adverse events, and longer-term cervical health to inform whether a less invasive option could preserve function with similar effectiveness.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Female, 25-60 years, understands study procedures and consents to participate;
2. Colposcopy-guided cervical biopsy within 3 months showing HSIL/CIN2;
3. Provides written informed consent.

Exclusion Criteria:

1. Cytology showing ASC-H, HSIL, AGC, or AIS; or evidence of malignant cells on cytology/histology, or suspicion of malignancy or invasive cancer;
2. Colposcopy findings suggestive of invasive cancer or lesion extension to the vaginal wall;
3. Severe pelvic, cervical, or other gynecological inflammatory conditions identified clinically;
4. Undiagnosed vaginal bleeding;
5. Active allergic disease, porphyria, or history of allergy to the study drug or structurally similar agents;
6. Severe cardiovascular, neurological, psychiatric, endocrine, hepatic, or hematologic disorders; known immunodeficiency; long-term glucocorticoid or immunosuppressant use; active autoimmune disease; or other malignancies;
7. Pregnant or breastfeeding women;
8. History of hysterectomy, cervical cancer treatment, or cervical excision/ablation within 6 months (e.g., conization, LEEP, laser);
9. Use of interferon or antiviral therapy within 3 months;
10. Any other condition deemed unsuitable for participation by the investigator.

Where it's running

• Hangzhou Linping District first People's Hospital
  Hangzhou, Zhejiang, China Recruiting
• Women's Hospital School Of Medicine Zhejiang University
  Hangzhou, Zhejiang, China Not yet recruiting
• First People's Hospital of Hangzhou
  Hangzhou, Zhejiang, China Not yet recruiting
• First Affiliated Hospital of Ningbo University
  Ningbo, Zhejiang, China Not yet recruiting
• Shaoxing People's Hospital
  Shaoxing, Zhejiang, China Not yet recruiting

Study contacts

• Study coordinator: Xiaoyun Wang, Doctor
• Email: doctorwangxy@zju.edu.cn
• Phone: 15168479997

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Home-use dual-light antibacterial therapy for peri-implant mucositis around full-arch implants

  This study tests whether a home-use dual-light device added to standard care can better control gum inflammation around full-arch dental implants than standard care alone.

  Recruiting University of Medicine and Pharmacy at Ho Chi Minh City · Ho Chi Minh City, Cau Ong Lanh Ward · NCT07763431

• Genital warts treatment with CO2 laser plus Geniwa gel

  This study tests whether adding Geniwa gel to CO2 laser therapy helps genital warts clear up and stay away compared with CO2 laser plus placebo gel in adults with recurrent warts.

  Recruiting Phase 2 KTH Biopharma · Hanoi, None (International) · NCT07698886

• ALA-PDT for cervical LSIL with HPV16/18 in multiple centers

  This study tests whether aminolevulinic acid–mediated photodynamic therapy can treat cervical LSIL in people with HPV16/18 compared with just observation.

  Recruiting Second Affiliated Hospital, Zhejiang University, School of Medicine · Hangzhou, Zhejiang and 4 other locations · NCT07306247

• Q-Pad menstrual-pad test to detect high-risk HPV and cervical precancer

  This study tests whether a home menstrual-pad kit (Q-Pad) can detect high-risk HPV and cervical precancer in people referred for colposcopy after an abnormal Pap or HPV result.

  Recruiting at 3 sites Qurasense · New Haven, Connecticut and 2 other locations · NCT07281599

• Papillex® for abnormal cervical cells caused by HPV

  This trial will see if taking Papillex® for 180 days helps abnormal cervical cells caused by HPV improve in women aged 25–55 with CIN 1 or 2.

  Recruiting Papillex Inc. · London, Ontario · NCT06979180

• Probiotics to Treat Anal HSIL in HIV Patients

  In people with HIV who have anal HSIL, this study tests whether a probiotic called EXE-346 can help clear lesions or reduce progression, compared with placebo.

  Recruiting Phase 2 University of California, San Francisco · San Francisco, California and 1 other locations · NCT06949800

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.