Research of Laser Ablation for the Treatment of Lower Anogenital Tracts' Precancerous Lesions

Study Overview
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Brief Summary
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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
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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.

Official Title
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Research of Multiple Targeting CO2 Laser Ablation for the Treatment of Lower Anogenital Tracts' Precancerous Lesions

Conditions
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Squamous Intraepithelial Lesions, Laser Burn

Intervention / Treatment
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* Procedure: laser ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients<br>Patients with squamous intraepithelial lesions of the lower anogenital tracts will receive laser ablation. | Procedure: laser ablation<br>* Laser ablation will be done for the squamous intraepithelial lesions of the lower anogenital tracts.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathological cure | No squamous intraepithelial lesions found by pathological examinations. | up to at least two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HPV clearance | The results of HPV tests are negative. | Every six months after initial treatment for at least two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laser, Cervical intraepithelial neoplasia, Vaginal intraepithelial neoplasia, Vulvar intraepithelial neoplasia, Anal intraepithelial neoplasia, Perianal intraepithelial neoplasia