Cervical Intraepithelial Neoplasia Grade 2 (CIN2)Lumiteg-RNCT07885566
RWS of PDT for CIN 2
An observational study of Cervical Intraepithelial Neoplasia Grade 2 (CIN2), run by Tongji Hospital.
Trial summary
This is a prospective, observational, multicenter real-world study designed to evaluate the effectiveness and safety of photodynamic therapy (PDT) in women with cervical intraepithelial neoplasia grade 2 (CIN2). Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Cervical Intraepithelial Neoplasia Grade 2 (CIN2)
- What is being tested?
- Hexaminolevulinate (HAL)
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Jun 2028to Mar 2029
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: This is a prospective, multicenter real-world cohort study. The study enrolls women aged 18-50 years with histopathologically confirmed cervical intraepithelial neoplasia grade 2 (CIN2) and positive HPV test. Eligible participants receive photodynamic therapy under routine clinical practice and are followed prospectively for up to 12 months to evaluate the real-world effectiveness and safety of PDT.
Who may be able to join
- Participants must meet all of the following criteria:
- Female participants aged 18 to 50 years.
- Histologically confirmed cervical intraepithelial neoplasia grade 2 (CIN2).
- Colposcopy demonstrates a fully visible transformation zone and the upper margin of the lesion (transformation zone type 1 or 2).
- Positive HPV test result.
- Treatment with photodynamic therapy (PDT) that is approved for the treatment of CIN2 in routine clinical practice.
Who cannot join
- Participants meeting any of the following criteria will be excluded:
- Histologically confirmed or highly suspected cervical invasive cancer, adenocarcinoma in situ, or high-grade glandular intraepithelial lesion.
- Current pregnancy or breastfeeding, or plans to become pregnant during the study period through 3 months after the last PDT treatment.
- Any contraindication to PDT, including:
- Cervical invasive cancer, adenocarcinoma in situ, endocervical intraepithelial neoplasia, or other glandular epithelial lesions;
- A history of toxic shock syndrome;
Show all 17Show fewer
- Porphyria;
- Known hypersensitivity to hexyl 5-aminolevulinate, aminolevulinate derivatives, or any excipients;
- Severe gynecological infection identified by colposcopy or clinical examination;
- Menstruation or vaginal bleeding;
- Silicone allergy;
- Presence of a cardiac pacemaker;
- Cervical anatomical abnormalities or incomplete cervical anatomy resulting from previous surgery that prevent use of the single-use cervical PDT lamp;
- Delivery or abortion within 6 weeks before enrollment.
- Any cervical treatment within 3 months before enrollment, including but not limited to loop electrosurgical excision procedure (LEEP), cold-knife conization, ablation, cryotherapy, or other local physical or chemical treatment.
- Known severe immunodeficiency, such as active acquired immunodeficiency syndrome (AIDS), uncontrolled autoimmune disease, or long-term systemic treatment with immunosuppressive agents (continuous use for 2 weeks or longer), chemotherapy, or other treatments that, in the investigator's judgment, may substantially affect immune status or interfere with assessment of treatment effectiveness.
- Any other condition that, in the investigator's medical judgment, may expose the participant to unacceptable risk or substantially interfere with data collection or interpretation.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Real-World Study of Photodynamic Therapy for Cervical Intraepithelial Neoplasia Grade 2
This is a prospective, observational, multicenter real-world study designed to evaluate the effectiveness and safety of photodynamic therapy (PDT) in women with cervical intraepithelial neoplasia grade 2 (CIN2).
Approximately 1,000 women aged 18 to 50 years with biopsy-confirmed CIN2 and a positive human papillomavirus (HPV) test will be enrolled. Participants will receive PDT that is approved for the treatment of CIN2 in routine clinical practice. Treatment will be administered according to the approved product labeling and the treating physician's clinical judgment. As this is an observational real-world study, the number and timing of PDT treatments will not be prespecified and will be recorded according to routine clinical practice.
Read more
Participants will be followed for 12 months after the initial PDT treatment. The primary outcome is the pathological remission rate at 6 months after the initial PDT treatment. Pathological remission is defined as a cervical biopsy showing normal tissue or CIN1/low-grade squamous intraepithelial lesion (LSIL).
Secondary outcomes include HPV clearance rates at 3 and 6 months, the incidence and severity of treatment-related adverse events, and the pathological remission rate at 12 months. Exploratory analyses will evaluate the association between available HPV-related biomarkers, including HPV integration status, and treatment outcomes.
- Being tested
- Hexaminolevulinate (HAL)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hexaminolevulinate (HAL)Combination product
Participants will receive photodynamic therapy (PDT) that is approved for the treatment of CIN2 in routine clinical practice. PDT will be administered according to the approved product labeling. The treating physician will determine the actual treatment schedule based on the participant's clinical condition and routine clinical practice. The number and interval of PDT treatments will not be prespecified by the study protocol and will be recorded as administered.
| Study group | Role | What they receive |
|---|---|---|
| CIN2 patients receiving routine clinical PDT | This cohort consists of female patients aged 18-50 years with histopathologically confirmed cervical intraepithelial neoplasia grade 2 (CIN2) and positive HPV test.
All participants receive photodynamic therapy (PDT) approved for CIN2 in routine clinical practice. The decision to administer PDT, as well as treatment times and intervals, are determined by attending clinicians according to product instructions and clinical conditions, not mandated by this study protocol.
Baseline and follow-up assessments including TCT, HPV testing, colposcopy-guided biopsy and HPV integration testing will be performed as specified in the study to evaluate real-world effectiveness and safety of PDT. Receives: Combination Product: Hexaminolevulinate (HAL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Remission Rate at 6 Months
Pathological remission is defined as a cervical biopsy showing normal tissue or CIN1/low-grade squamous intraepithelial lesion (LSIL). The pathological remission rate is the proportion of participants meeting this definition at 6 months after the initial PDT treatment.
Measured: 6 months after the initial PDT treatment
Secondary outcomes (4)
HPV Clearance Rate at 3 Months
The proportion of participants with clearance of HPV infection at 3 months after the initial PDT treatment, based on HPV testing.
Measured: 3 months after the initial PDT treatment
HPV Clearance Rate at 6 Months
The proportion of participants with clearance of HPV infection at 6 months after the initial PDT treatment, based on HPV testing.
Measured: 6 months after the initial PDT treatment
Incidence and Severity of Treatment-Related Adverse Events
The incidence and severity of adverse events considered related to PDT will be recorded. Adverse event severity will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
Measured: From the first PDT treatment through the 12-month follow-up period
Pathological Remission Rate at 12 Months
The proportion of participants with pathological remission at 12 months after the initial PDT treatment. Pathological remission is defined as a cervical biopsy showing normal tissue or CIN1/LSIL.
Measured: 12 months after the initial PDT treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study startJun 2028 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Intraepithelial Neoplasia Grade 2 (CIN2)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu Nan, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07885566
- Sponsor's protocol ID
- TJ-IRB202609064
- Acronym
- Lumiteg-R
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No