High-Grade Squamous Intraepithelial LesionsNCT06333743
Laser Ablation in the Treatment of High-grade Cervical Lesions
A study testing laser ablation and LEEP or Conization in people with High-Grade Squamous Intraepithelial Lesions, run by Peking Union Medical College Hospital.
Trial summary
Cervical laser ablation is an effective, minimally invasive treatment with a low incidence of perinatal complications and minimal impact on fertility. Research has confirmed that laser ablation treatment of cervical HSIL (including CIN2 and CIN3) is effective and feasible and is useful for young CIN3 patients who wish… Read more about this study
- Who is it for?
- Ages Up to 40 years, women only
- Conditions the study is for
- High-Grade Squamous Intraepithelial Lesions
- What is being tested?
- laser ablation and LEEP or Conization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 308 participants
- Where
- No sites listed yet
- Study dates
- May 2024to May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Up to 40 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- < 40-year-old
- Cervical HSIL confirmed by colposcopic biopsy pathology
- Cervical transformation zone type 1 or 2
- The lesion is completely visible and does not extend into the cervical canal, and the lesion area is less than 50% of the cervical surface area
- Colposcopic evaluation ruled out invasive cancer
- Voluntary participation in the study with full and informed consent
Who cannot join
- Cervical transformation zone type 3
- Glandular epithelial lesions
- Lesions greater than 50% of cervical surface area, or with vaginal and vulvar intraepithelial lesions
- The upper margin of the lesion was not visible or extended into the cervical canal
- Cervical tube sampling was diagnosed with CIN2+ or CIN that could not be graded
- Cervical biopsy is not sufficient to confirm a tissue diagnosis
Show all 11Show fewer
- Suspected invasive cancer
- History of cervical surgery
- Pregnancy or planning a pregnancy during study participation
- Autoimmune or immune deficiency diseases
- Long-term use of immunosuppressive drugs
Trial locations and contacts
No sites are listed yet.
Jinhui Wang, MD contact
About this study
Official title: Efficacy, Acceptability, and Safety of Laser Ablation in the Treatment of High-grade Cervical Lesions: a Randomized Clinical Trial
Cervical laser ablation is an effective, minimally invasive treatment with a low incidence of perinatal complications and minimal impact on fertility. Research has confirmed that laser ablation treatment of cervical HSIL (including CIN2 and CIN3) is effective and feasible and is useful for young CIN3 patients who wish to get pregnant in the future. There have been no randomized clinical trials of laser ablation therapy for cervical HSIL in Chinese women. This study focuses on the application of laser ablation in the treatment of cervical HSIL, explores the efficacy, feasibility, and safety of laser ablation in the treatment of cervical HSIL, and strives to promote the reasonable application of laser ablation in the treatment of cervical HSIL.
Read the detailed description
- Background This study focuses on the application of laser ablation in the treatment of cervical HSIL, explores the efficacy, feasibility, and safety of laser ablation in the treatment of cervical HSIL, and strives to promote the reasonable application of laser ablation in the treatment of cervical HSIL.
- Research objects Young patients with cervical HSIL underwent colposcopic evaluation, completed cervical biopsy, and were pathologically confirmed to be eligible for ablation.
- Methods 3.1 Sample size This study was a randomized controlled trial with parallel design. HSIL recurrence rate was the primary endpoint. According to previous literature reports, it is estimated that the recurrence rate of HSIL in the laser treatment group is 15%. The recurrence rate of HSIL in the resection group was 5%. Let α=0.05 (both sides), hold =0.80. Using PASS 11 software, the sample size of both groups was 138 cases. Assuming that the loss of follow-up rate of the study subjects was 10%, the sample size of each group was 138÷0.9=154 cases. Therefore, 308 patients were intended to be included in the study. 3.2 Statistical methods SPSS 24.0 software will be used for statistical analysis of all data. Measurement data with normal distribution will be described by mean ± standard deviation. Independent sample t-test or rank sum test will be used for inter-group comparison, and paired sample t-test will be used for intra-group comparison before and after treatment. Counting data will be expressed as examples or percentages (%), and the Chi-square test will be used for comparison between groups. The Kaplan-Meier method will be used to calculate the recurrence rate, and the rank sum test will be used to evaluate the difference between the two groups. Cox regression model will be used to analyze the factors influencing prognosis. P < 0.05 will be considered statistically significant.
- Results The primary endpoint is the HSIL recurrence rate at 12 months after treatment.
Other subjects were secondary study endpoints shown as follows:
Intraoperative and postoperative complications and side effects, including bleeding, pain, infection, cervical secretions, and healing; Psychological state change; Satisfaction; Cervical length; Recurrence rate; Fees
- Being tested
- laser ablation, LEEP or Conization
- Keywords
- HSIL, laser ablation
- Medical subject headings
- Squamous Intraepithelial Lesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laser ablationProcedure or surgery
Research has confirmed that laser ablation treatment of cervical HSIL is effective and feasible.
LEEP or ConizationProcedure or surgery
The most common treatment for HSIL is LEEP or conization of the cervical lesion, but there are several perinatal complications involved in this surgery.
| Study group | Role | What they receive |
|---|---|---|
| laser ablation treatment | Experimental | Laser vaporization is performed using a carbon dioxide laser under colposcopy. All patients received 1% mepivacaine hydrochloride paracervix block. No general anesthesia was used. Before laser vaporization began, scaly columnar nodules were visible in all patients. The evaporation depth is 8-10mm, and the edge is 5mm from the abnormal discovery or transition area. Receives: Procedure: laser ablation |
| LEEP or conization treatment | Active comparator | The cervix was stained with iodine solution and the diseased lesion was visualized. LEEP or conization was performed to a depth of approximately 1.5 cm to resect disease in the cervical canal. Receives: Procedure: LEEP or Conization |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of HSIL recurrence
12 months after the treatment, TCT, HPV, colposcopy, and biopsy will be tested again. If the result of the biopsy is HSIL again, we will record it as HSIL recurrence.
Measured: 12 months after treatment
Secondary outcomes (3)
the satisfaction with the treatment
after the treatment, patients will fill in a questionnaire to describe their degree of satisfaction with the treatment
Measured: 8 weeks and 12 months after treatment
the length of the cervix
the length of the cervix will be measured by B-ultrasound
Measured: 8 weeks and 12 months after treatment
Psychological state change related to the treatment
State-Trait Anxiety Inventory，STAI-Form Y will be used to measure the patients' psychological state after treatment.
Measured: 8 weeks and 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study startMay 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for High-Grade Squamous Intraepithelial LesionsStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 308 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Obstetrics & Gynecology Hospital of Fudan University
- Responsible party
- Sponsor
- Investigators
- Lan Zhu, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06333743
- Sponsor's protocol ID
- ZhuLan
- Status last verified
- Mar 2024
- First submitted
- 25 Feb 2024
- Last updated
- 27 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Perkins RB, Guido RS, Castle PE, Chelmow D, Einstein MH, Garcia F, Huh WK, Kim JJ, Moscicki AB, Nayar R, Saraiya M, Sawaya GF, Wentzensen N, Schiffman M; 2019 ASCCP Risk-Based Management Consensus Guidelines Committee. 2019 ASCCP Risk-Based Management Consensus Guidelines for Abnormal Cervical Cancer Screening Tests and Cancer Precursors. J Low Genit Tract Dis. 2020 Apr;24(2):102-131. doi: 10.1097/LGT.0000000000000525. No abstract available.
PubMed 32243307Sadler L, Saftlas A, Wang W, Exeter M, Whittaker J, McCowan L. Treatment for cervical intraepithelial neoplasia and risk of preterm delivery. JAMA. 2004 May 5;291(17):2100-6. doi: 10.1001/jama.291.17.2100.
PubMed 15126438Kyrgiou M, Koliopoulos G, Martin-Hirsch P, Arbyn M, Prendiville W, Paraskevaidis E. Obstetric outcomes after conservative treatment for intraepithelial or early invasive cervical lesions: systematic review and meta-analysis. Lancet. 2006 Feb 11;367(9509):489-98. doi: 10.1016/S0140-6736(06)68181-6.
PubMed 16473126Fallani MG, Penna C, Fambrini M, Marchionni M. Laser CO2 vaporization for high-grade cervical intraepithelial neoplasia: a long-term follow-up series. Gynecol Oncol. 2003 Oct;91(1):130-3. doi: 10.1016/s0090-8258(03)00440-2.
PubMed 14529672Mariya T, Nishikawa A, Sogawa K, Suzuki R, Saito M, Kawamata A, Shimizu A, Nihei T, Sonoda T, Saito T. Virological and cytological clearance in laser vaporization and conization for cervical intra-epithelial neoplasia grade 3. J Obstet Gynaecol Res. 2016 Dec;42(12):1808-1813. doi: 10.1111/jog.13113. Epub 2016 Aug 16.
PubMed 27526956Zhang L, Sauvaget C, Mosquera I, Basu P. Efficacy, acceptability and safety of ablative versus excisional procedure in the treatment of histologically confirmed CIN2/3: A systematic review. BJOG. 2023 Jan;130(2):153-161. doi: 10.1111/1471-0528.17251. Epub 2022 Jul 4.
PubMed 35689493Yoon BS, Seong SJ, Song T, Kim ML, Kim MK. Risk factors for treatment failure of CO2 laser vaporization in cervical intraepithelial neoplasia 2. Arch Gynecol Obstet. 2014 Jul;290(1):115-9. doi: 10.1007/s00404-014-3148-1. Epub 2014 Jan 24.
PubMed 24458427Kodama K, Yahata H, Okugawa K, Tomonobe H, Yasutake N, Yoshida S, Yagi H, Yasunaga M, Ohgami T, Onoyama I, Asanoma K, Hori E, Shimokawa M, Kato K. Prognostic outcomes and risk factors for recurrence after laser vaporization for cervical intraepithelial neoplasia: a single-center retrospective study. Int J Clin Oncol. 2021 Apr;26(4):770-776. doi: 10.1007/s10147-020-01848-x. Epub 2021 Jan 4.
PubMed 33394202Inaba K, Nagasaka K, Kawana K, Arimoto T, Matsumoto Y, Tsuruga T, Mori-Uchino M, Miura S, Sone K, Oda K, Nakagawa S, Yano T, Kozuma S, Fujii T. High-risk human papillomavirus correlates with recurrence after laser ablation for treatment of patients with cervical intraepithelial neoplasia 3: a long-term follow-up retrospective study. J Obstet Gynaecol Res. 2014 Feb;40(2):554-60. doi: 10.1111/jog.12196. Epub 2013 Oct 11.
PubMed 24118526
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy, Acceptability, and Safety of Laser Ablation in the Treatment of High-grade Cervical Lesions: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06333743
- Acronym / sponsor ID
- ZhuLan
- Keywords
- HSIL, laser ablation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 308 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Obstetrics & Gynecology Hospital of Fudan University
- Study start
- May 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 27 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cervical laser ablation is an effective, minimally invasive treatment with a low incidence of perinatal complications and minimal impact on fertility. Research has confirmed that laser ablation treatment of cervical HSIL (including CIN2 and CIN3) is effective and feasible and is useful for young CIN3 patients who wish to get pregnant in the future. There have been no randomized clinical trials of laser ablation therapy for cervical HSIL in Chinese women. This study focuses on the application of laser ablation in the treatment of cervical HSIL, explores the efficacy, feasibility, and safety of laser ablation in the treatment of cervical HSIL, and strives to promote the reasonable application of laser ablation in the treatment of cervical HSIL.
Detailed description
- Background This study focuses on the application of laser ablation in the treatment of cervical HSIL, explores the efficacy, feasibility, and safety of laser ablation in the treatment of cervical HSIL, and strives to promote the reasonable application of laser ablation in the treatment of cervical HSIL.
- Research objects Young patients with cervical HSIL underwent colposcopic evaluation, completed cervical biopsy, and were pathologically confirmed to be eligible for ablation.
- Methods 3.1 Sample size This study was a randomized controlled trial with parallel design. HSIL recurrence rate was the primary endpoint. According to previous literature reports, it is estimated that the recurrence rate of HSIL in the laser treatment group is 15%. The recurrence rate of HSIL in the resection group was 5%. Let α=0.05 (both sides), hold =0.80. Using PASS 11 software, the sample size of both groups was 138 cases. Assuming that the loss of follow-up rate of the study subjects was 10%, the sample size of each group was 138÷0.9=154 cases. Therefore, 308 patients were intended to be included in the study. 3.2 Statistical methods SPSS 24.0 software will be used for statistical analysis of all data. Measurement data with normal distribution will be described by mean ± standard deviation. Independent sample t-test or rank sum test will be used for inter-group comparison, and paired sample t-test will be used for intra-group comparison before and after treatment. Counting data will be expressed as examples or percentages (%), and the Chi-square test will be used for comparison between groups. The Kaplan-Meier method will be used to calculate the recurrence rate, and the rank sum test will be used to evaluate the difference between the two groups. Cox regression model will be used to analyze the factors influencing prognosis. P < 0.05 will be considered statistically significant.
- Results The primary endpoint is the HSIL recurrence rate at 12 months after treatment.
Other subjects were secondary study endpoints shown as follows:
Intraoperative and postoperative complications and side effects, including bleeding, pain, infection, cervical secretions, and healing; Psychological state change; Satisfaction; Cervical length; Recurrence rate; Fees
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laser ablation treatment | Experimental | Procedure: laser ablationLaser vaporization is performed using a carbon dioxide laser under colposcopy. All patients received 1% mepivacaine hydrochloride paracervix block. No general anesthesia was used. Before laser vaporization began, scaly columnar nodules were visible in all patients. The evaporation depth is 8-10mm, and the edge is 5mm from the abnormal discovery or transition area. |
| LEEP or conization treatment | Active comparator | Procedure: LEEP or ConizationThe cervix was stained with iodine solution and the diseased lesion was visualized. LEEP or conization was performed to a depth of approximately 1.5 cm to resect disease in the cervical canal. |
Who may qualify
- Ages
- Up to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- < 40-year-old
- Cervical HSIL confirmed by colposcopic biopsy pathology
- Cervical transformation zone type 1 or 2
- The lesion is completely visible and does not extend into the cervical canal, and the lesion area is less than 50% of the cervical surface area
- Colposcopic evaluation ruled out invasive cancer
Key exclusion criteria (11 listed)
- Cervical transformation zone type 3
- Glandular epithelial lesions
- Lesions greater than 50% of cervical surface area, or with vaginal and vulvar intraepithelial lesions
- The upper margin of the lesion was not visible or extended into the cervical canal
- Cervical tube sampling was diagnosed with CIN2+ or CIN that could not be graded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laser ablationResearch has confirmed that laser ablation treatment of cervical HSIL is effective and feasible. | Procedure or surgery | laser ablation treatment |
| LEEP or ConizationThe most common treatment for HSIL is LEEP or conization of the cervical lesion, but there are several perinatal complications involved in this surgery. | Procedure or surgery | LEEP or conization treatment |
Primary outcome
the rate of HSIL recurrence
Time frame: 12 months after treatment
12 months after the treatment, TCT, HPV, colposcopy, and biopsy will be tested again. If the result of the biopsy is HSIL again, we will record it as HSIL recurrence.
3 secondary outcomes
the satisfaction with the treatment
Time frame: 8 weeks and 12 months after treatment
the length of the cervix
Time frame: 8 weeks and 12 months after treatment
Psychological state change related to the treatment
Time frame: 8 weeks and 12 months after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
- Background: PubMed 32243307Perkins RB, Guido RS, Castle PE, Chelmow D, Einstein MH, Garcia F, Huh WK, Kim JJ, Moscicki AB, Nayar R, Saraiya M, Sawaya GF, Wentzensen N, Schiffman M; 2019 ASCCP Risk-Based Management Consensus Guidelines Committee. 2019 ASCCP Risk-Based Management Consensus Guidelines for Abnormal Cervical Cancer Screening Tests and Cancer Precursors. J Low Genit Tract Dis. 2020 Apr;24(2):102-131. doi: 10.1097/LGT.0000000000000525. No abstract available.
- Background: PubMed 15126438Sadler L, Saftlas A, Wang W, Exeter M, Whittaker J, McCowan L. Treatment for cervical intraepithelial neoplasia and risk of preterm delivery. JAMA. 2004 May 5;291(17):2100-6. doi: 10.1001/jama.291.17.2100.
- Background: PubMed 16473126Kyrgiou M, Koliopoulos G, Martin-Hirsch P, Arbyn M, Prendiville W, Paraskevaidis E. Obstetric outcomes after conservative treatment for intraepithelial or early invasive cervical lesions: systematic review and meta-analysis. Lancet. 2006 Feb 11;367(9509):489-98. doi: 10.1016/S0140-6736(06)68181-6.
- Background: PubMed 14529672Fallani MG, Penna C, Fambrini M, Marchionni M. Laser CO2 vaporization for high-grade cervical intraepithelial neoplasia: a long-term follow-up series. Gynecol Oncol. 2003 Oct;91(1):130-3. doi: 10.1016/s0090-8258(03)00440-2.
- Results publication: PubMed 27526956Mariya T, Nishikawa A, Sogawa K, Suzuki R, Saito M, Kawamata A, Shimizu A, Nihei T, Sonoda T, Saito T. Virological and cytological clearance in laser vaporization and conization for cervical intra-epithelial neoplasia grade 3. J Obstet Gynaecol Res. 2016 Dec;42(12):1808-1813. doi: 10.1111/jog.13113. Epub 2016 Aug 16.
- Results publication: PubMed 35689493Zhang L, Sauvaget C, Mosquera I, Basu P. Efficacy, acceptability and safety of ablative versus excisional procedure in the treatment of histologically confirmed CIN2/3: A systematic review. BJOG. 2023 Jan;130(2):153-161. doi: 10.1111/1471-0528.17251. Epub 2022 Jul 4.
- Results publication: PubMed 24458427Yoon BS, Seong SJ, Song T, Kim ML, Kim MK. Risk factors for treatment failure of CO2 laser vaporization in cervical intraepithelial neoplasia 2. Arch Gynecol Obstet. 2014 Jul;290(1):115-9. doi: 10.1007/s00404-014-3148-1. Epub 2014 Jan 24.
- Results publication: PubMed 33394202Kodama K, Yahata H, Okugawa K, Tomonobe H, Yasutake N, Yoshida S, Yagi H, Yasunaga M, Ohgami T, Onoyama I, Asanoma K, Hori E, Shimokawa M, Kato K. Prognostic outcomes and risk factors for recurrence after laser vaporization for cervical intraepithelial neoplasia: a single-center retrospective study. Int J Clin Oncol. 2021 Apr;26(4):770-776. doi: 10.1007/s10147-020-01848-x. Epub 2021 Jan 4.
- Results publication: PubMed 24118526Inaba K, Nagasaka K, Kawana K, Arimoto T, Matsumoto Y, Tsuruga T, Mori-Uchino M, Miura S, Sone K, Oda K, Nakagawa S, Yano T, Kozuma S, Fujii T. High-risk human papillomavirus correlates with recurrence after laser ablation for treatment of patients with cervical intraepithelial neoplasia 3: a long-term follow-up retrospective study. J Obstet Gynaecol Res. 2014 Feb;40(2):554-60. doi: 10.1111/jog.12196. Epub 2013 Oct 11.
- WHO guidelines for the use of thermal ablation for cervical pre-cancer lesionsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for High-Grade Squamous Intraepithelial Lesions
RecruitingPhase 2
CASCADE 2002: PROTECT Study, "PRObiotics to TrEat Anal preCancer Trial
HSIL, High Grade Squamous Intraepithelial Lesion, HPV-Related Squamous Cell Carcinoma
Active, not recruitingObservational study
Predictive Biomarkers for Precision Management of Pre-cancerous Cervical Neoplasia
HSIL, High Grade Squamous Intraepithelial Lesion, DNA Methylation
Recruiting
Multicenter Prospective Non-randomized Controlled Study of Ella Photodynamic Therapy for Cervical HSIL/CIN2
HSIL, High Grade Squamous Intraepithelial Lesion, CIN 2
Active, not recruiting
Screening Algorithms for Cervical and Anal High-Grade Squamous Intraepithelial Lesions in People With HIV in Mexico and Puerto Rico
AIDS-Related Anal Carcinoma, AIDS-Related Cervical Carcinoma
Active, not recruitingObservational study
Anal High-risk HPV, HSIL, and Microbiome Among Hispanic Peoples Living With HIV (PLWH)
Human Immunodeficiency Virus, Human Papillomavirus-Related Anal Squamous Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jinhui Wang, MD contact
Lan Zhu, MD principal investigator
Peking Union Medical College Hospital
Questions about this trial
What is this clinical trial studying?
A study testing laser ablation and LEEP or Conization in people with High-Grade Squamous Intraepithelial Lesions, run by Peking Union Medical College Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lan Zhu, MD (86-010-69156874, zhulan@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the rate of HSIL recurrence (time frame: 12 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06333743, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2024.