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Diagnostic Cervical Conization for Persistent Infection or Integration of HPV

Primary Purpose

Human Papilloma Virus Infection, Human Papilloma Virus Integration, Cervical Intraepithelial Neoplasia

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
diagnostic cervical conization
Sponsored by
Tongji Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Human Papilloma Virus Infection focused on measuring HPV persistent infection, HPV integration, diagnostic cervical conization

Eligibility Criteria

25 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients

Arm 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.

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

Full Information

First Posted
August 16, 2022
Last Updated
September 7, 2022
Sponsor
Tongji Hospital
Collaborators
National Natural Science Foundation of China
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1. Study Identification

Unique Protocol Identification Number
NCT05510830
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2022 (Anticipated)
Primary Completion Date
January 2028 (Anticipated)
Study Completion Date
January 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tongji Hospital
Collaborators
National Natural Science Foundation of China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Papilloma Virus Infection, Human Papilloma Virus Integration, Cervical Intraepithelial Neoplasia, Cervical Cancer, Cervical Conization
Keywords
HPV persistent infection, HPV integration, diagnostic cervical conization

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
diagnostic cervical conization
Intervention 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.
Primary Outcome Measure Information:
Title
The incidence of discovering concealed cervical cancer or percancerous lesions
Description
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.
Time Frame
up to 2 months after recruited
Title
The incidence of HPV clearance after the cervical conization
Description
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
Time Frame
Through the study completion, an average of 3~5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shuang Li, M.D
Phone
18971625668
Email
lee5190008@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dongli Kong, M.D
Phone
15107173860
Email
kongdongli1988@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shuang Li, M.D
Organizational Affiliation
Tongji Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
350000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Every six month, we will check if there is a new subject recruited in the study and update the data.

Learn more about this trial

Diagnostic Cervical Conization for Persistent Infection or Integration of HPV

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