Trial · NCT07891338
Exploratory Study of the Efficacy of HAL-PDT in CIN 3
NCT07891338, Phase 2, Not yet recruiting, Tongji Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Exploratory Study of the Efficacy of HAL-PDT in CIN 3. Trials, record NCT07891338. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07891338
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Exploratory Study of the Efficacy of HAL-PDT in CIN 3
- NCT number
- NCT07891338
- Status
- Not yet recruiting
- Phases
- Phase 2
- Enrollment
- 260 participants, estimated
- Lead sponsor
- Tongji Hospital
- Conditions
- Cervical Intraepithelial Neoplasia Grade 3
- Interventions
- Hexaminolevulinate (HAL)
- First posted
- 2026-10-23
- Last updated
- 2026-10-23
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pathological Regression Rate at 6 Months | 180 ±14 days after the first HAL-PDT treatment | The protocol defines the primary endpoint as the 6-month pathological regression rate, with regression defined as histopathological downgrade to normal cervical tissue or LSIL/CIN1. |
| Secondary | Colposcopic Lesion Changes at 3 Months | 90 ±7 days after the first HAL-PDT treatment | Changes in cervical lesion morphology and lesion extent assessed by colposcopy. No biopsy will be performed at this visit. |
| Secondary | Pathological Regression Rate at 12 Months | 360 ±30 days after the first HAL-PDT treatment | The proportion of participants who achieve pathological regression at the 12-month assessment. Pathological regression is defined as a colposcopy-guided cervical biopsy showing normal cervical tissue or LSIL/CIN1. |
| Secondary | HPV Clearance Rate at 3 Months | 90 ±7 days after the first HAL-PDT treatment | The proportion of participants who become negative for the HPV genotype detected at baseline |
| Secondary | HPV Clearance Rate at 6 Months | 180 ±14 days after the first HAL-PDT treatment | The proportion of participants who become negative for the HPV genotype detected at baseline. |
| Secondary | HPV Clearance Rate at 12 Months | 360 ±30 days after the first HAL-PDT treatment | The proportion of participants who become negative for the HPV genotype detected at baseline. |
| Secondary | Treatment-Related Adverse Events | From the first HAL-PDT treatment through the end of the study | Incidence and characteristics of treatment-related adverse events associated with HAL-PDT, assessed according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0. |
| Secondary | Correlation Between Baseline HPV Integration Status and 6-Month Pathological Response Rate | Baseline HPV integration assessment and 180 ±14 days after the first HAL-PDT treatment | Baseline HPV integration status will be measured and be categorized as positive or negative, with a semi-quantitative integration level reported. Pathological response is defined as histologic regression to normal cervical tissue or low-grade squamous intraepithelial lesion (LSIL/CIN1) at Month 6 (D180), assessed by colposcopy-directed cervical biopsy with histopathological examination, and is reported as the percentage of participants with response. |
| Secondary | Correlation Between Baseline HPV Integration Status and HPV Clearance Rate | Baseline and 3, 6, and 12 months after the first HAL-PDT treatment | Baseline HPV integration status will be measured categorized as positive or negative with a semi-quantitative integration level. HPV clearance is defined as negativity for the baseline HPV genotype(s) at 3, 6 and 12 months after treatment, and is reported as the percentage of participants with clearance. |
| Secondary | Cervical Exfoliated-Cell Gene Methylation Status | 90 ±7 days and 180 ±14 days after the first HAL-PDT treatment | Changes in methylation status of selected genes in cervical exfoliated cells. The protocol specifies that genes may include PAX1 and ZNF582. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07891338
GET https://conductscience.org/api/trials/v1/NCT07891338/registered