NCT07606677

Brief Summary

This prospective, multicenter cohort study will recruit eligible HPV16/18-positive women from three tertiary hospitals in China. Peripheral blood samples and clinical data (cytology, HPV genotyping, colposcopy-directed biopsy) will be collected, followed by standardized mass cytometry (CyTOF) to develop and evaluate an immune model across cervical lesion grades.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,465

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started May 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress11%
May 2026Mar 2028

First Submitted

Initial submission to the registry

May 6, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

May 15, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 26, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2028

Last Updated

May 26, 2026

Status Verified

May 1, 2026

Enrollment Period

11 months

First QC Date

May 6, 2026

Last Update Submit

May 18, 2026

Conditions

CIN 2/3Cervical Cancer (Early Detection)

Keywords

cervical cancerCervical Intraepithelial NeoplasiaHPV16/18Mass cytometryImmune model

Outcome Measures

Primary Outcomes (3)

  • The diagnostic sensitivity of the CyTOF-based immune model for detecting CIN3+ lesions in HPV16/18-positive women

    through study completion, an average of 1 year

  • AUC of the CyTOF-based immune model for detecting CIN3+ lesions in HPV16/18-positive women

    through study completion, an average of 1 year

  • The diagnostic specificity of the CyTOF-based immune model for detecting CIN3+ lesions in HPV16/18-positive women

    through study completion, an average of 1 year

Secondary Outcomes (8)

  • The diagnostic sensitivity of the CyTOF-based immune model for detecting CIN2+ lesions in HPV16/18-positive women，

    through study completion, an average of 1 year

  • AUC of the CyTOF-based immune model for detecting CIN2+ lesions in HPV16/18-positive women

    through study completion, an average of 1 year

  • The diagnostic specificity of the CyTOF-based immune model for detecting CIN2+ lesions in HPV16/18-positive women

    through study completion, an average of 1 year

  • Compare the CyTOF-based immune model's accuracy with those of conventional screening methods (including cytology, HPV genotyping, and colposcopy-directed cervical biopsy)

    through study completion, an average of 1 year

  • Compare the CyTOF-based immune model's positive predictive values with those of conventional screening methods (including cytology, HPV genotyping, and colposcopy-directed cervical biopsy)

    through study completion, an average of 1 year

  • +3 more secondary outcomes

Eligibility Criteria

Age25 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

HPV16/18-positive patients

You may qualify if:

  • Availability of cervical cytology results
  • Consent to colposcopy and cervical biopsy
  • Signed informed consent

You may not qualify if:

  • Confirmed diagnosis of CIN2 or worse
  • Prior cervical ablation, cervical conization, chemoradiotherapy, or immunotherapy
  • Other malignancy within the past 2 years not in complete remission
  • Presence of other systemic immune disease or active infection
  • Pregnancy or lactation
  • Inability to comply with follow-up and examinations
  • Inability to comply with study procedures, restrictions, and requirements, as determined by the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Uterine Cervical NeoplasmsUterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesPrecancerous Conditions

Central Study Contacts

Junfen Xu

CONTACT

+86 13567147767xjfzu@zju.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 6, 2026

First Posted

May 26, 2026

Study Start

May 15, 2026

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2028

Last Updated

May 26, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

All data relevant to the study will be generated in the article or uploaded as supplementary information. Deidentified participant data will be available from Dr. Hui Wang (wang71hui@zju.edu.cn) on a reasonable request. Protocols and statistical analysis plans will be included as supplementary information.