Clinical trial NCT05510830: Diagnostic Cervical Conization for Persistent Infection or Integration of HPV
Official title: A Study of the Value of Diagnostic Cervical Conization for Persistent Infection or Integration of Human Papillomavirus
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Human Papilloma Virus Infection
Human Papilloma Virus Integration
Cervical Intraepithelial Neoplasia
Cervical Cancer
Cervical Conization
Keywords: HPV persistent infection
HPV integration
diagnostic cervical conization
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
Collaborators: name: National Natural Science Foundation of China
First posted: 2022-08-22
Enrollment: 250
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

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.

Primary outcomes:
measure: The incidence of discovering concealed cervical cancer or percancerous lesions
timeFrame: up to 2 months after recruited
measure: The incidence of HPV clearance after the cervical conization
timeFrame: Through the study completion, an average of 3~5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Shuang Li, M.D
role: PRINCIPAL_INVESTIGATOR
References: