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

Laser Burn Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05170620
• Other study ID #: TJ-IRB20210134
• Status: Recruiting
• Phase: N/A
• Start date: November 8, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2021
• Source: Tongji Hospital
• Contact: Shuang Li, Doctor
• Phone: +86 18971625668
• Email: lee5190008[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Laser Burn
• Squamous Intraepithelial Lesions of the Cervix

Intervention

Procedure:
• laser ablation
Laser ablation will be done for the squamous intraepithelial lesions of the lower anogenital tracts.

Locations

Country	Name	City	State
China	Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathological cure	No squamous intraepithelial lesions found by pathological examinations.	up to at least two years
Secondary	HPV clearance	The results of HPV tests are negative.	Every six months after initial treatment for at least two years