High-grade Squamous Intraepithelial Lesions (HSIL)NCT06713655
Predicting Treatment Failure in HSIL Patients with Positive Margins After Conization Via Detection of PAX1 Methylation
An observational study of High-grade Squamous Intraepithelial Lesions (HSIL) and Cervical Conization, run by Women's Hospital School Of Medicine Zhejiang University at 1 site in China.
Trial summary
The goal of this multicenter, observational study is to evaluate whether methylation testing of paired box gene 1 (PAX1) can better predict and diagnose recurrence or persistent disease in patients with positive margins after cervical conization for high-grade squamous intraepithelial lesion (HSIL). Read more about this study
- Who is it for?
- Ages 26 to 54 years, women only
- Conditions the study is for
- High-grade Squamous Intraepithelial Lesions (HSIL), Cervical Conization
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- Dec 2024to Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 26 to 54 years
- Women only
- No healthy volunteers
- Adult
Study population: Women undergoing their first cervical conization surgery for treatment or diagnosis at seven hospitals mentioned above in Zhejiang Province.
Who may be able to join
- Age greater than 25 years and less than 55 years;
- First-time cervical conization (cold knife conization or loop electrosurgical excision procedure);
- Postoperative pathology showing HSIL (CIN2 or CIN3);
- Positive margins for HSIL (CIN2 or CIN3) in conization specimen.
Who cannot join
- The presence of other malignant tumors or precancerous lesions;
- Lack of willingness for follow-up;
- Pregnant or breastfeeding women;
- Unable or unwilling to complete follow-up examinations;
- History of prior cervical disease treatment (surgical or physical therapy);
- Presence of immune system disorders.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Women's Hospital School Of Medicine Zhejiang University
Hangzhou, Zhejiang, 310000
Lv Weiguo, 0086-0571-87061501, lbwg@zju.edu.cn
About this study
Official title: Multicenter Study on PAX1 Methylation for Predicting Lesion Persistence/Recurrence in HSIL Patients with Positive Margins After Cervical Conization
The goal of this multicenter, observational study is to evaluate whether methylation testing of paired box gene 1 (PAX1) can better predict and diagnose recurrence or persistent disease in patients with positive margins after cervical conization for high-grade squamous intraepithelial lesion (HSIL). The main question it aims to answer is:
Can PAX1 gene methylation testing provide a more accurate and effective prediction and diagnosis of cervical disease recurrence/persistence in addition to existing methods? Participants will be managed according to the latest clinical guidelines, and during follow-up, a non-invasive test, PAX1 gene methylation testing, will be added.
Read the detailed description
This study is a multicenter, prospective observational study that qualitatively assesses the methylation status of the PAX1 gene in cervical exfoliated cells from patients with HSIL and positive margins after conization. The aim is to evaluate the ability of PAX1 gene methylation testing to predict treatment failure (lesion recurrence or persistence). The first follow-up occurs 6 months post-surgery, including high-risk human papillomavirus (hrHPV) testing and cytology, with referral for colposcopy, including biopsy and/or endocervical curettage (ECC), if necessary. Subsequent management and follow-up are based on examination results, following clinical guidelines, and arranged at intervals of 6-12 months depending on the findings. The follow-up includes routine clinical examinations widely applied in practice, and PAX1 testing will be completed at each follow-up visit. PAX1 testing, like hrHPV testing and cytology, will be performed using cervical exfoliated cells.
- Keywords
- cervical intraepithelial neoplasia, conization, positive margins, cervical cancer, treatment failure, residual/recurrent disease
- Medical subject headings
- Squamous Intraepithelial Lesions, Uterine Cervical Dysplasia, Margins of Excision, Uterine Cervical Neoplasms, Recurrence
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment failure rate within 24 months after surgery (cervical intraepithelial neoplasia grade 2+ (CIN2+) recurrence/residual rates)
the percentage of HSIL treatment failure (CIN2+ recurrence and residual) within 24 months after surgery
Measured: 2 years post-surgery
Sensitivity of the PAX1 methylation to detect treatment failure
Measured: 2 years post-surgery
specificity of the PAX1 methylation to detect treatment failure
Measured: 2 years post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2024
- Study startDec 2024 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-grade Squamous Intraepithelial Lesions (HSIL)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
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Huzhou Maternity and Child Care Hospital, Jiaxing Maternity and Child Health Care Hospital, Shaoxing Maternity and Child Health Care Hospital, Ningbo No. 1 Hospital, Jinhua Central Hospital, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
- Responsible party
- Principal investigator, Weiguo Lv, Women's Hospital School Of Medicine Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06713655
- Sponsor's protocol ID
- IRB-20240248-R
- Status last verified
- Oct 2024
- First submitted
- 27 Nov 2024
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Study on PAX1 Methylation for Predicting Lesion Persistence/Recurrence in HSIL Patients with Positive Margins After Cervical Conization
- ClinicalTrials.gov ID
- NCT06713655
- Acronym / sponsor ID
- IRB-20240248-R
- Keywords
- cervical intraepithelial neoplasia, conization, positive margins, cervical cancer, treatment failure, residual/recurrent disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Huzhou Maternity and Child Care Hospital, Jiaxing Maternity and Child Health Care Hospital, Shaoxing Maternity and Child Health Care Hospital, Ningbo No. 1 Hospital, Jinhua Central Hospital, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
- Study start
- Dec 2024 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 3 Dec 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.
The goal of this multicenter, observational study is to evaluate whether methylation testing of paired box gene 1 (PAX1) can better predict and diagnose recurrence or persistent disease in patients with positive margins after cervical conization for high-grade squamous intraepithelial lesion (HSIL). The main question it aims to answer is:
Can PAX1 gene methylation testing provide a more accurate and effective prediction and diagnosis of cervical disease recurrence/persistence in addition to existing methods? Participants will be managed according to the latest clinical guidelines, and during follow-up, a non-invasive test, PAX1 gene methylation testing, will be added.
Detailed description
This study is a multicenter, prospective observational study that qualitatively assesses the methylation status of the PAX1 gene in cervical exfoliated cells from patients with HSIL and positive margins after conization. The aim is to evaluate the ability of PAX1 gene methylation testing to predict treatment failure (lesion recurrence or persistence). The first follow-up occurs 6 months post-surgery, including high-risk human papillomavirus (hrHPV) testing and cytology, with referral for colposcopy, including biopsy and/or endocervical curettage (ECC), if necessary. Subsequent management and follow-up are based on examination results, following clinical guidelines, and arranged at intervals of 6-12 months depending on the findings. The follow-up includes routine clinical examinations widely applied in practice, and PAX1 testing will be completed at each follow-up visit. PAX1 testing, like hrHPV testing and cytology, will be performed using cervical exfoliated cells.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 26 to 54 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women undergoing their first cervical conization surgery for treatment or diagnosis at seven hospitals mentioned above in Zhejiang Province.
Key inclusion criteria (4 listed)
- Age greater than 25 years and less than 55 years;
- First-time cervical conization (cold knife conization or loop electrosurgical excision procedure);
- Postoperative pathology showing HSIL (CIN2 or CIN3);
- Positive margins for HSIL (CIN2 or CIN3) in conization specimen.
Key exclusion criteria (6 listed)
- The presence of other malignant tumors or precancerous lesions;
- Lack of willingness for follow-up;
- Pregnant or breastfeeding women;
- Unable or unwilling to complete follow-up examinations;
- History of prior cervical disease treatment (surgical or physical therapy);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Treatment failure rate within 24 months after surgery (cervical intraepithelial neoplasia grade 2+ (CIN2+) recurrence/residual rates)
Time frame: 2 years post-surgery
the percentage of HSIL treatment failure (CIN2+ recurrence and residual) within 24 months after surgery
Sensitivity of the PAX1 methylation to detect treatment failure
Time frame: 2 years post-surgery
specificity of the PAX1 methylation to detect treatment failure
Time frame: 2 years post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of High-grade Squamous Intraepithelial Lesions (HSIL) and Cervical Conization, run by Women's Hospital School Of Medicine Zhejiang University at 1 site in China.
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 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lv Weiguo, Ph.D (86-13588819218, lbwg@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment failure rate within 24 months after surgery (cervical intraepithelial neoplasia grade 2+ (CIN2+) recurrence/residual rates) (time frame: 2 years post-surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Dec 2024.