Diagnostic Cervical Conization for Persistent Infection or Integration of HPV

N/ANot Yet RecruitingNCT05510830

Tongji Hospital250 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

250

Conditions

Human Papilloma Virus Infection Human Papilloma Virus Integration Cervical Intraepithelial Neoplasia Cervical Cancer Cervical Conization

Interventions

diagnostic cervical conizationPROCEDURE

For the patients who met the inclusion criteria, the gynecologists perform cervical conization and pathological examinations. Then the patients will be followed-up for at least two years with the tests of cervical TCT \& HPV, and colposcopy if necessary. The data will be analyzed and see if the patients with high risk factors benefit from the surgery or not.

Eligibility

Sex: FEMALEMin age: 25 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

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

Wuhan, Hubei, China

Outcomes

Primary Outcomes

The incidence of discovering concealed cervical cancer or percancerous lesions

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.

Time frame: up to 2 months after recruited

The incidence of HPV clearance after the cervical conization

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

Time frame: Through the study completion, an average of 3~5 years

Central Contacts

Shuang Li, M.D

CONTACT

18971625668 lee5190008@126.com

Dongli Kong, M.D

CONTACT

15107173860 kongdongli1988@163.com

Data from ClinicalTrials.gov

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