Squamous Intraepithelial LesionsNCT05170620
Research of Laser Ablation for the Treatment of Lower Anogenital Tracts' Precancerous Lesions
A study testing laser ablation in people with Squamous Intraepithelial Lesions and Laser Burn, run by Tongji Hospital at 1 site in China.
Trial summary
Using multiple targeting CO2 laser ablation to treat the precancerous lesion of the female lower anogenital tracts and analyzing the data collected in the study, we aim to form the standard strategy of laser ablation method to increase the effective rate and lower the rate of relapse and progression. Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Squamous Intraepithelial Lesions, Laser Burn
- What is being tested?
- laser ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 8 Nov 2019to 31 Dec 2024
- 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 16 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Had the history of sexual life.
- Transferred to colposcopy examination and biopsy for abnormal screening of cervical cancer, contact bleeding of cervix, recurrent discomfort of vulva or abnormal signs of lower genital and anal tract. The pathology of biopsy indicate CIN, VaIN, VIN, AIN, or PaIN.
- If CIN, the colposcopy manifests transformation zone-1 which means the lesion can totally be seen. However the consideration of fertility damage of resection overweighs the chance of suffering cancer.
- The patients can accept multiple laser ablations and colposcopy examinations and follow-up at least 2 years.
Who cannot join
- Patients who are suffering cancers of other systems and in treatment.
- Patients suffering acute inflammation of lower genital and anal tracts.
- The colposcopy and pathology examination suspect of cancer of lower genital and anal tract.
- Patients suffering severe diseases such as insufficiency of liver and kidney function, diseases of blood system and other acute infections who will get heath harm from colposcopy and laser vaporization.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Shuang Li, Doctor, +86 18971625668, lee5190008@126.com
Dongli Kong, Doctor, +86 15107173860, kongdongli1988@163.com
About this study
Official title: Research of Multiple Targeting CO2 Laser Ablation for the Treatment of Lower Anogenital Tracts' Precancerous Lesions
Using multiple targeting CO2 laser ablation to treat the precancerous lesion of the female lower anogenital tracts and analyzing the data collected in the study, we aim to form the standard strategy of laser ablation method to increase the effective rate and lower the rate of relapse and progression.
Read the detailed description
Patients diagnosed with CIN, VaIN, VIN, AIN or PAIN are recruited with exclusion of suspicion of malignant tumors. We use multiple targeting CO2 laser ablation to treat the precancerous lesion of the female lower anogenital tracts and then follow up the patients for at least two years. By analyzing the data collected in the study, we aim to form the standard strategy of laser ablation method to increase the effective rate and lower the rate of relapse and progression.
- Conditions
- Squamous Intraepithelial Lesions, Laser Burn
- Being tested
- laser ablation
- Keywords
- laser, Cervical intraepithelial neoplasia, Vaginal intraepithelial neoplasia, Vulvar intraepithelial neoplasia, Anal intraepithelial neoplasia, Perianal intraepithelial neoplasia
- Medical subject headings
- Squamous Intraepithelial Lesions, Uterine Cervical Dysplasia, Bowen's Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laser ablationProcedure or surgery
Laser ablation will be done for the squamous intraepithelial lesions of the lower anogenital tracts.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Patients with squamous intraepithelial lesions of the lower anogenital tracts will receive laser ablation. Receives: Procedure: laser ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological cure
No squamous intraepithelial lesions found by pathological examinations.
Measured: up to at least two years
Secondary outcomes (1)
HPV clearance
The results of HPV tests are negative.
Measured: Every six months after initial treatment for at least two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2021
- Study start8 Nov 2019
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Intraepithelial LesionsStudies of the same condition, open and under way.
- More trials run by Tongji 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shuang Li, Doctor, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05170620
- Sponsor's protocol ID
- TJ-IRB20210134
- Status last verified
- Jan 2021
- First submitted
- 24 Dec 2021
- Last updated
- 28 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 28 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research of Multiple Targeting CO2 Laser Ablation for the Treatment of Lower Anogenital Tracts' Precancerous Lesions
- ClinicalTrials.gov ID
- NCT05170620
- Acronym / sponsor ID
- TJ-IRB20210134
- Conditions
- Squamous Intraepithelial Lesions, Laser Burn
- Keywords
- laser, Cervical intraepithelial neoplasia, Vaginal intraepithelial neoplasia, Vulvar intraepithelial neoplasia, Anal intraepithelial neoplasia, Perianal intraepithelial neoplasia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 8 Nov 2019 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 28 Dec 2021 (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.
Using multiple targeting CO2 laser ablation to treat the precancerous lesion of the female lower anogenital tracts and analyzing the data collected in the study, we aim to form the standard strategy of laser ablation method to increase the effective rate and lower the rate of relapse and progression.
Detailed description
Patients diagnosed with CIN, VaIN, VIN, AIN or PAIN are recruited with exclusion of suspicion of malignant tumors. We use multiple targeting CO2 laser ablation to treat the precancerous lesion of the female lower anogenital tracts and then follow up the patients for at least two years. By analyzing the data collected in the study, we aim to form the standard strategy of laser ablation method to increase the effective rate and lower the rate of relapse and progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Procedure: laser ablationPatients with squamous intraepithelial lesions of the lower anogenital tracts will receive laser ablation. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Had the history of sexual life.
- Transferred to colposcopy examination and biopsy for abnormal screening of cervical cancer, contact bleeding of cervix, recurrent discomfort of vulva or abnormal signs of lower genital and anal tract. The pathology of biopsy indicate CIN, VaIN, VIN, AIN, or PaIN.
- If CIN, the colposcopy manifests transformation zone-1 which means the lesion can totally be seen. However the consideration of fertility damage of resection overweighs the chance of suffering cancer.
- The patients can accept multiple laser ablations and colposcopy examinations and follow-up at least 2 years.
Key exclusion criteria (4 listed)
- Patients who are suffering cancers of other systems and in treatment.
- Patients suffering acute inflammation of lower genital and anal tracts.
- The colposcopy and pathology examination suspect of cancer of lower genital and anal tract.
- Patients suffering severe diseases such as insufficiency of liver and kidney function, diseases of blood system and other acute infections who will get heath harm from colposcopy and laser vaporization.
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 ablationLaser ablation will be done for the squamous intraepithelial lesions of the lower anogenital tracts. | Procedure or surgery | Patients |
Primary outcome
Pathological cure
Time frame: up to at least two years
No squamous intraepithelial lesions found by pathological examinations.
1 secondary outcome
HPV clearance
Time frame: Every six months after initial treatment for at least two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2021.
- 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. This study is not recruiting at the moment.
Shuang Li, Doctor principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laser ablation in people with Squamous Intraepithelial Lesions and Laser Burn, run by Tongji Hospital 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 4 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 28 Dec 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shuang Li, Doctor (+86 18971625668, lee5190008@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological cure (time frame: up to at least two years). 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 28 Dec 2021.