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Trial Title:
Diagnostic Cervical Conization for Persistent Infection or Integration of HPV
NCT ID:
NCT05510830
Condition:
Human Papilloma Virus Infection
Human Papilloma Virus Integration
Cervical Intraepithelial Neoplasia
Cervical Cancer
Cervical Conization
Conditions: Official terms:
Infections
Communicable Diseases
Papillomavirus Infections
Persistent Infection
Papilloma
Uterine Cervical Dysplasia
Conditions: Keywords:
HPV persistent infection
HPV integration
diagnostic cervical conization
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
diagnostic cervical conization
Description:
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.
Arm group label:
Patients
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.
Criteria for eligibility:
Criteria:
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.
Gender:
Female
Minimum age:
25 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Address:
City:
Wuhan
Zip:
350000
Country:
China
Start date:
October 2022
Completion date:
January 2030
Lead sponsor:
Agency:
Tongji Hospital
Agency class:
Other
Collaborator:
Agency:
National Natural Science Foundation of China
Agency class:
Other
Source:
Tongji Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05510830
