Diagnostic Cervical Conization for Persistent Infection or Integration of HPV

Cervical Cancer Clinical Trial

Official title:

A Study of the Value of Diagnostic Cervical Conization for Persistent Infection or Integration of Human Papillomavirus

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05510830
• Other study ID #: TJ-IRB20220769
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2022
• Est. completion date: January 2030

Study information

• Verified date: September 2022
• Source: Tongji Hospital
• Contact: Shuang Li, M.D
• Phone: 18971625668
• Email: lee5190008[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: January 2030
• Est. primary completion date: January 2028
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Cancer
• Cervical Intraepithelial Neoplasia
• Communicable Diseases
• Human Papilloma Virus Infection
• Infections
• Papilloma
• Papillomavirus Infections

Intervention

Procedure:
• diagnostic cervical conization
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.

Locations

Country	Name	City	State
China	Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (2)

Lead Sponsor	Collaborator
Tongji Hospital	National Natural Science Foundation of China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 2 months after recruited
Primary	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	Through the study completion, an average of 3~5 years