Diagnostic Cervical Conization for Persistent Infection or Integration of HPV

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age25-70
SponsorTongji Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

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.

Disqualifiers

Pregnant women.

Vaginal intraepithelial neoplasia is highly suspected by colposcopy and pathological examinations.

The patients are suffering malignant tumors of other system and have not been cured.

There is acute inflammation of the lower genital or anal tract.

Trial design

Design model

Single group

Treatments tested in this trial

  • diagnostic cervical conization

    Procedure/Surgery

    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.

Treatment groups

250 Participants
are divided into 1 treatment group
Group A: PatientsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tongji Hospital

Lead sponsor

National Natural Science Foundation of China

Collaborator

This trial is not recruiting at the moment. You can still explore other options: