NCT05170620

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 8, 2019

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

December 24, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 28, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

December 28, 2021

Status Verified

January 1, 2021

Enrollment Period

4.1 years

First QC Date

December 24, 2021

Last Update Submit

December 27, 2021

Conditions

Squamous Intraepithelial LesionsLaser Burn

Keywords

laserCervical intraepithelial neoplasiaVaginal intraepithelial neoplasiaVulvar intraepithelial neoplasiaAnal intraepithelial neoplasiaPerianal intraepithelial neoplasia

Outcome Measures

Primary Outcomes (1)

  • Pathological cure

    No squamous intraepithelial lesions found by pathological examinations.

    up to at least two years

Secondary Outcomes (1)

  • HPV clearance

    Every six months after initial treatment for at least two years

Study Arms (1)

Patients

EXPERIMENTAL

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

Procedure: laser ablation

Interventions

laser ablationPROCEDURE

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

Patients

Eligibility Criteria

Age16 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThis study focus on diseases of the female reproductive system.
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Conditions

Squamous Intraepithelial LesionsUterine Cervical DysplasiaBowen's Disease

Interventions

Laser Therapy

Condition Hierarchy (Ancestors)

Morphological and Microscopic FindingsPathological Conditions, Signs and SymptomsPrecancerous ConditionsNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

TherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Shuang Li, Doctor

    Tongji Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shuang Li, Doctor

CONTACT

+86 18971625668lee5190008@126.com

Dongli Kong, Doctor

CONTACT

+86 15107173860kongdongli1988@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 24, 2021

First Posted

December 28, 2021

Study Start

November 8, 2019

Primary Completion

December 31, 2023

Study Completion

December 31, 2024

Last Updated

December 28, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)