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 volunteersQualifiers
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
Single group
Treatments tested in this trial
diagnostic cervical conization
Procedure/SurgeryFor 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
Trial 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.
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
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: