Diagnostic Cervical Conization for Persistent Infection or Integration of HPV

NCT05510830 | Not Yet Recruiting

• 1 other identifier: TJ-IRB20220769
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

Patients

EXPERIMENTAL

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.

Procedure: diagnostic cervical conization

Interventions

diagnostic cervical conization PROCEDURE

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.

Patients

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patients are referred to colposcopy and biopsy examinations due to abnormal cervical screening results with no precancerous lesions discovered by pathology.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Tongji Hospital: lead
• National Natural Science Foundation of China: collaborator

Study Sites (1)

Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, 350000, China

Location

MeSH Terms

Conditions

Papillomavirus Infections; Uterine Cervical Dysplasia; Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site

Study Officials

• Shuang Li, M.D

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shuang Li, M.D

CONTACT

18971625668; lee5190008@126.com

Dongli Kong, M.D

CONTACT

15107173860; kongdongli1988@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 16, 2022
• First Posted: August 22, 2022
• Study Start: October 1, 2022
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2030
• Last Updated: September 8, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

CN (1)