Brief Title
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
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.
Study Type
Interventional
Primary Outcome
The incidence of discovering concealed cervical cancer or percancerous lesions
Condition
Human Papilloma Virus Infection
Intervention
diagnostic cervical conization
Study Arms / Comparison Groups
Patients
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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
250
Start Date
October 2022
Completion Date
January 2030
Primary Completion Date
January 2028
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
Ages
25 Years - 70 Years
Accepts Healthy Volunteers
No
Contacts
Shuang Li, M.D, 18971625668, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT05510830
Organization ID
TJ-IRB20220769
Responsible Party
Principal Investigator
Study Sponsor
Tongji Hospital
Collaborators
National Natural Science Foundation of China
Study Sponsor
Shuang Li, M.D, Principal Investigator, Tongji Hospital
Verification Date
September 2022