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Not yet recruiting NCT05510830

Diagnostic Cervical Conization for Persistent Infection or Integration of HPV

No phase Interventional Human Papilloma Virus Infection Human Papilloma Virus Integration Cervical Intraepithelial Neoplasia Cervical Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: diagnostic cervical conization.
Who it may be relevant to
Registry conditions: Human Papilloma Virus Infection, Human Papilloma Virus Integration, Cervical Intraepithelial Neoplasia, Cervical Cancer. Basic parameters: 25 years — 70 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • The incidence of discovering concealed cervical cancer or percancerous lesions [Time frame: up to 2 months after recruited]
  • The incidence of HPV clearance after the cervical conization [Time frame: Through the study completion, an average of 3~5 years]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

China · 1 center
  • Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and — Wuhan

Identifiers

NCT: NCT05510830 · TJ-IRB20220769

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗