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

Tongji Hospital

Status: Enrolling

Conditions: Laser Burn; Squamous Intraepithelial Lesions

Treatments: Procedure: laser ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT05170620

TJ-IRB20210134

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

200 participants in 1 patient group

Patients

Experimental group

Description:

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

Treatment:

Procedure: laser ablation