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NCT Number: NCT05510830

Diagnostic Cervical Conization for Persistent Infection or Integration of HPV

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. The incidence of discovering concealed cervical cancer or percancerous lesions

    Time frame: up to 2 months after recruited

    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.

  2. The incidence of HPV clearance after the cervical conization

    Time frame: Through the study completion, an average of 3~5 years

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Dongli Kong, M.D

CONTACT

[email protected]

15107173860

Shuang Li, M.D

CONTACT

[email protected]

18971625668

Sponsors and collaborators

Lead sponsor

Tongji Hospital

Other

Collaborators

  • National Natural Science Foundation of China

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2028
Study completion
2030
First posted
Aug 22, 2022
Registry last updated
Sep 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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