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Trial Title:
Clinical Evaluation of HPV Integration Triage for Detection of Cervical Precancer in HPV-positive Women
NCT ID:
NCT05570331
Condition:
HPV Infection
Cervical Cancer
Conditions: Official terms:
Papillomavirus Infections
Uterine Cervical Neoplasms
Uterine Cervical Dysplasia
Conditions: Keywords:
Cervical cancer screening, HPV test, HPV integration
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
HPV integration test
Description:
HPV-positive patients who are eligible for cervical cancer screening will be asked to
collect Cervical Exfoliated Cells sample for the HPV integration screening test and for
the HPV testing and TCT.
Summary:
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.
Detailed 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.
Criteria for eligibility:
Study pop:
aged 20y-70y HPV-positive women
Sampling method:
Probability Sample
Criteria:
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
Gender:
Female
Minimum age:
20 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Tongji Hospital, Tongji Medical College Huazhong University of Science and Technology
Address:
City:
Wuhan
Zip:
430000
Country:
China
Status:
Recruiting
Contact:
Last name:
Ting Hu, MD,PhD
Phone:
+862783662681
Email:
cat_huting@163.com
Start date:
January 1, 2022
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Ding Ma
Agency class:
Other
Source:
Tongji Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05570331
