Trial · NCT07891338
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| 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. |
| Secondary | Cervical Exfoliated-Cell p16/Ki-67 Dual-Stain Status | 90 ±7 days and 180 ±14 days after the first HAL-PDT treatment | p16/Ki-67 dual-stain status in cervical exfoliated-cell specimens during follow-up.The protocol specifies assessment of cervical exfoliated-cell methylation and p16/Ki-67 dual-stain status at 3 and 6 months. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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GET https://conductscience.org/api/trials/v1/NCT07891338/registered