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

NCT ID: NCT05170620

Last Updated: 2021-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-08

Study Completion Date

2024-12-31

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.

Conditions

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Squamous Intraepithelial Lesions Laser Burn

Keywords

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laser Cervical intraepithelial neoplasia Vaginal intraepithelial neoplasia Vulvar intraepithelial neoplasia Anal intraepithelial neoplasia Perianal intraepithelial neoplasia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patients

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

Group Type EXPERIMENTAL

laser ablation

Intervention Type PROCEDURE

Laser ablation will be done for the squamous intraepithelial lesions of the lower anogenital tracts.

Interventions

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laser ablation

Laser ablation will be done for the squamous intraepithelial lesions of the lower anogenital tracts.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Tongji Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shuang Li, Doctor

Role: PRINCIPAL_INVESTIGATOR

Tongji Hospital

Locations

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Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shuang Li, Doctor

Role: CONTACT

Phone: +86 18971625668

Email: [email protected]

Dongli Kong, Doctor

Role: CONTACT

Phone: +86 15107173860

Email: [email protected]

Facility Contacts

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Shuang Li, Doctor

Role: primary

Dongli Kong, Doctor

Role: backup

Other Identifiers

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TJ-IRB20210134

Identifier Type: -

Identifier Source: org_study_id