Light therapy could replace surgery for cervical precancer
NCT ID NCT07306260
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study compares a light-activated gel treatment (ALA-PDT) to standard surgery (LEEP) for women with high-grade cervical precancer (HSIL/CIN2). About 560 women will receive either the gel plus red light therapy or surgery. The goal is to see if the gel treatment works as well as surgery, with fewer side effects and less impact on fertility.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ALA-PDT (aminolevulinic acid photodynamic therapy)
- What this could lead to
- If it works, this could offer a less invasive, tissue-sparing alternative to surgery for treating cervical precancerous lesions, potentially reducing side effects and preserving fertility.
- What could go wrong
- This is a non-randomized study, so results may be less reliable. The treatment requires multiple sessions, and it may not be as effective as surgery in the long term. HPV clearance is not guaranteed.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 560 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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25 to 65 years
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
5 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, China
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First People's Hospital of Hangzhou
Hangzhou, Zhejiang, China
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Hangzhou Linping District first People's Hospital
Hangzhou, Zhejiang, China
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Shaoxing People's Hospital
Shaoxing, Zhejiang, China
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Women's Hospital School Of Medicine Zhejiang University
Hangzhou, Zhejiang, 310000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a light wand tame implant gum inflammation at home?
- Could a gel stop genital warts from coming back?
- HPV vaccine education trial aims to overcome parental hesitancy
- HPV pill trial aims to clear precancerous cells without surgery
- HPV education trial aims to boost screening and vaccination among young women
- Light therapy shows promise against HPV-Linked cervical precancer