Peripheral Blood CyTOF Immune Model for Cervical Lesion Detection in HPV16/18+ Women (NCT07606677) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Peripheral Blood CyTOF Immune Model for Cervical Lesion Detection in HPV16/18+ Women
1,465 participantsStarted 2026-05-15
Plain-language 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.
Who can participate
Age range
25 Years – 65 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Availability of cervical cytology results
* Consent to colposcopy and cervical biopsy
* Signed informed consent
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The diagnostic sensitivity of the CyTOF-based immune model for detecting CIN3+ lesions in HPV16/18-positive women
Timeframe: through study completion, an average of 1 year
2
AUC of the CyTOF-based immune model for detecting CIN3+ lesions in HPV16/18-positive women
Timeframe: through study completion, an average of 1 year
3
The diagnostic specificity of the CyTOF-based immune model for detecting CIN3+ lesions in HPV16/18-positive women
Timeframe: through study completion, an average of 1 year
Trial details
NCT IDNCT07606677
SponsorWomen's Hospital School Of Medicine Zhejiang University