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Light therapy could replace surgery for cervical precancer

NCT ID NCT07306260

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 560 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

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

25 to 65 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • First Affiliated Hospital of Ningbo University

    Ningbo, Zhejiang, China

  • First People's Hospital of Hangzhou

    Hangzhou, Zhejiang, China

  • Hangzhou Linping District first People's Hospital

    Hangzhou, Zhejiang, China

  • Shaoxing People's Hospital

    Shaoxing, Zhejiang, China

  • Women's Hospital School Of Medicine Zhejiang University

    Hangzhou, Zhejiang, 310000, China

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