Diagnostic Cervical Conization for Persistent Infection or Integration of HPV

Not Applicable

Not yet recruiting

• Conditions: Human Papilloma Virus Infection; Cervical Intraepithelial Neoplasia; Cervical Conization; Cervical Cancer; Human Papilloma Virus Integration
• Interventions: Procedure: diagnostic cervical conization

• Registration Number: NCT05510830
• Lead Sponsor: Tongji Hospital

Brief Summary

For the patients with cervical persistent infection or integration of HPV, we has designed a program to perform cervical conization for certain patients to earlier and better diagnose and cure the diseases of HPV infection and related cervical intraepithelial neoplasia/cancer.

Detailed Description

For the patients with cervical persistent infection or integration of human papillomavirus, the incidence of suffering cervical cancer or percancerous lesions increases. As the biopsy guided by colposcopy might miss some lesions, the cervical conization plays a role for the patients with high risk factors to diagnose the related cervical diseases. In this study, we has designed a program to perform cervical conization for certain patients to earlier and better diagnose and cure the diseases of HPV infection and related cervical intraepithelial neoplasia/cancer.

Study Timeline

• Study First Submitted: 2022-08-16
• Study First Submitted QC: 2022-08-19
• Study First Posted: 2022-08-22
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-07
• Last Update Posted: 2022-09-08
• Study Start: 2022-10
• Primary Completion: 2028-01
• Study Completion: 2030-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 250

Inclusion Criteria

1. The patients are referred to colposcopy and biopsy examinations due to abnormal cervical screening results with no precancerous lesions discovered by pathology.

2. The cervical precancerous lesions are highly suspected by clinicians with one or more following risk factors:

   • The course of HPV type 16/18 persistent infection is more than two years.
   • The integration reads of HPV is more than 15.
   • The impression of colposcopy indicates precancerous lesions.
   • The cervical TCT indicates ASC-H/HSIL/SCC/AGC-FN/AIS/AC.

Exclusion Criteria

1. Pregnant women.
2. Vaginal intraepithelial neoplasia is highly suspected by colposcopy and pathological examinations.
3. The patients are suffering malignant tumors of other system and have not been cured.
4. There is acute inflammation of the lower genital or anal tract.
5. The patients' health will be severely harmed by the colposcopy and cervical conization due to some circumstances such as severe insufficiency of liver and kidney function, blood diseases and acute inflammation of other systems.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients	diagnostic cervical conization	The patients who meet the inclusion criteria will receive diagnostic cervical conization for pathological examinations. Then they will be followed up for at least two years with every six months' return to our clinics to test HPV and colposcopy if necessary.

Primary Outcome Measures

Name	Time	Method
The incidence of discovering concealed cervical cancer or percancerous lesions	up to 2 months after recruited	The pathological examinations of the cervical conization might discover some concealed cervical cancer or precancerous lesions which could not be discovered by biopsy guided by colposcopy.
The incidence of HPV clearance after the cervical conization	Through the study completion, an average of 3~5 years	After the cervical conizations, the patients will be arranged for follow-up every six months and HPV will be tested to see if the virus is cleared or not

Trial Locations

Locations (1)

Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China