Diagnostic Cervical Conization for Persistent Infection or Integration of HPV

Tongji Hospital

Status: Not yet enrolling

Conditions: Human Papilloma Virus Integration; Cervical Conization; Human Papilloma Virus Infection; Cervical Intraepithelial Neoplasia; Cervical Cancer

Treatments: Procedure: diagnostic cervical conization

Study type: Interventional

Funder types: Other

Identifiers

NCT05510830

TJ-IRB20220769

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 estimated patients

Sex: Female

Ages: 25 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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250 participants in 1 patient group

Patients

Experimental group

Description:

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.

Treatment:

Procedure: diagnostic cervical conization