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

Not Applicable

Recruiting

• Conditions: Squamous Intraepithelial Lesions; Laser Burn
• Interventions: Procedure: laser ablation

• Registration Number: NCT05170620
• Lead Sponsor: Tongji Hospital

Brief 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.

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 Timeline

• Study Start: 2019-11-08
• Status Verified: 2021-01
• Study First Submitted: 2021-12-24
• Study First Submitted QC: 2021-12-27
• Last Update Submitted: 2021-12-27
• Study First Posted: 2021-12-28
• Last Update Posted: 2021-12-28
• Primary Completion: 2023-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

1. Had the history of sexual life.
2. 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.
3. 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.
4. The patients can accept multiple laser ablations and colposcopy examinations and follow-up at least 2 years.

Exclusion Criteria

1. Patients who are suffering cancers of other systems and in treatment.
2. Patients suffering acute inflammation of lower genital and anal tracts.
3. The colposcopy and pathology examination suspect of cancer of lower genital and anal tract.
4. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients	laser ablation	Patients with squamous intraepithelial lesions of the lower anogenital tracts will receive laser ablation.

Primary Outcome Measures

Name	Time	Method
Pathological cure	up to at least two years	No squamous intraepithelial lesions found by pathological examinations.

Secondary Outcome Measures

Name	Time	Method
HPV clearance	Every six months after initial treatment for at least two years	The results of HPV tests are negative.

Trial Locations

Locations (1)

Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China