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

Primary Purpose

Squamous Intraepithelial Lesions, Laser Burn

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

laser ablation

About this trial

This is an interventional treatment trial for Squamous Intraepithelial Lesions focused on measuring laser, Cervical intraepithelial neoplasia, Vaginal intraepithelial neoplasia, Vulvar intraepithelial neoplasia, Anal intraepithelial neoplasia, Perianal intraepithelial neoplasia

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients

Arm Description

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

Outcomes

Primary Outcome Measures

Pathological cure

No squamous intraepithelial lesions found by pathological examinations.

Secondary Outcome Measures

HPV clearance

The results of HPV tests are negative.

Full Information

NCT ID

NCT05170620

First Posted

December 24, 2021

Last Updated

December 27, 2021

Sponsor

Tongji Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05170620

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Recruiting

Study Start Date

November 8, 2019 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tongji Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Squamous Intraepithelial Lesions, Laser Burn

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Patients

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

laser ablation

Intervention Description

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

Primary Outcome Measure Information:

Title

Pathological cure

Description

No squamous intraepithelial lesions found by pathological examinations.

Time Frame

up to at least two years

Secondary Outcome Measure Information:

Title

HPV clearance

Description

The results of HPV tests are negative.

Time Frame

Every six months after initial treatment for at least two years

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

This study focus on diseases of the female reproductive system.

Minimum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Shuang Li, Doctor

Phone

+86 18971625668

lee5190008@126.com

First Name & Middle Initial & Last Name or Official Title & Degree

Dongli Kong, Doctor

Phone

+86 15107173860

kongdongli1988@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shuang Li, Doctor

Organizational Affiliation

Tongji Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Wuhan

State/Province

Hubei

ZIP/Postal Code

430030

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shuang Li, Doctor

Phone

+86 18971625668

lee5190008@126.com

First Name & Middle Initial & Last Name & Degree

Dongli Kong, Doctor

Phone

+86 15107173860

kongdongli1988@163.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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