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Clinical Evaluation of HPV Integration Triage for Detection of Cervical Precancer in HPV-positive Women

D

Ding Ma

Status

Enrolling

Conditions

HPV Infection
Cervical Cancer

Treatments

Diagnostic Test: HPV integration test

Study type

Observational

Funder types

Other

Identifiers

NCT05570331
TJ-IRB20220142

Details and patient eligibility

About

The American Society for Colposcopy and Cervical Pathology (ASCCP) recommended HPV testing or co-cytology testing as the standard primary approach for cervical cancer (CC) screening, which is highly sensitive for detection of cervical intraepithelial neoplasia grade 3 or worse. However, in clinical CC screening practice, the specificity and positive predictive value of the ASCCP-recommended strategy is relatively low, which leads to excessive colposcopy and common overtreatment, especially in China with a large number of cervical cancer cases. HPV integration in the host genome is a critical step in cervical carcinogenesis and is highly specific for detection of cervical cancer. Whether HPV integration analysis can play a role in the triage of cervical cancer screening has not yet been investigated.

Full description

Based on the dilemma of the cervical cancer screening process, in the last five years, our team developed a novel cervical cancer triage strategy and conducted a large cohort study, which evaluated the clinical performance of HPV integration triage alone and in combination with HPV16/18 or HPV16 genotyping of HPV-positive women. We found that the specificity of HPV integration for greater than cervical intraepithelial neoplasia 3 was 94.5%, which was significantly higher than that of cytology (63.8%; P < 0.001) in our previous retrospective study.Here, we conducted a large prospective cohort study evaluating the clinical performance of HPV integration triage of HPV-positive women.

Enrollment

2,200 estimated patients

Sex

Female

Ages

20 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Consenting women aged 20y-70y with HPV-positive results

Exclusion criteria

  • Not providing informed consent
  • previously confirmed CIN, cervical cancer, or other malignancies
  • previous therapeutic procedure to cervix
  • pregnancy

Trial contacts and locations

1

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Central trial contact

Ting Hu, MD, PhD

Data sourced from clinicaltrials.gov

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