CIN 2/3NCT07606677
Peripheral Blood CyTOF Immune Model for Cervical Lesion Detection in HPV16/18+ Women
An observational study of CIN 2/3 and Cervical Cancer (Early Detection), run by Women's Hospital School Of Medicine Zhejiang University.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 65 years, women only
- Conditions the study is for
- CIN 2/3, Cervical Cancer (Early Detection)
- How many people
- 1,465 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2026to 31 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: HPV16/18-positive patients
Who may be able to join
- Availability of cervical cytology results
- Consent to colposcopy and cervical biopsy
- Signed informed consent
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Mass Cytometry-based Peripheral Blood Immune Model for Accurate Detection of Cervical Lesions in HPV16/18-positive Women: a Multicenter Study
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.
Read the detailed description
This study aimed to validate the diagnostic efficacy of our previously established CyTOF-based immune model for identifying CIN3+ lesions (including CIN3 and cervical cancer) in a multicenter prospective cohort of HPV16/18-positive women. In addition, this study seeks to promote the standardized implementation of mass cytometry in cervical lesion triage, construct a non-invasive, high-throughput and high-accuracy immune diagnostic workflow, improve the diagnostic efficiency and precision management of HPV16/18-positive populations, and minimize unnecessary invasive examinations as well as patients' psychological burden. Ultimately, it is expected to advance the precision-oriented optimization of national cervical cancer prevention strategies. Meanwhile, the feasibility and clinical superiority of this model will be evaluated by comparing it with current mainstream screening modalities, such as cervical cytology, HPV genotyping and colposcopy-guided cervical biopsy, which lays a solid foundation for the subsequent development of related auxiliary diagnostic reagents and products.(1)Primary objective: To validate the diagnostic efficacy (sensitivity, specificity, area under the curve [AUC]) of the CyTOF-based immune model for detecting CIN3+ lesions in HPV16/18-positive women.(2)Secondary objective: To validate the diagnostic efficacy (sensitivity, specificity, AUC) of the CyTOF-based immune model for detecting CIN2+ lesions in HPV16/18-positive women, and to compare its accuracy, positive and negative predictive values with those of conventional screening methods (including cytology, HPV genotyping, and colposcopy-directed cervical biopsy). (3)Exploratory objective: To investigate the adaptability and stability of the model across different populations (e.g., by age group and vaccination status).
- Conditions
- CIN 2/3, Cervical Cancer (Early Detection)
- Keywords
- cervical cancer, Cervical Intraepithelial Neoplasia, HPV16/18, Mass cytometry, Immune model
- Medical subject headings
- Uterine Cervical Neoplasms, Uterine Cervical Dysplasia
What is being measured
The primary outcome is the main question the study is designed to answer.
The diagnostic sensitivity of the CyTOF-based immune model for detecting CIN3+ lesions in HPV16/18-positive women
Measured: through study completion, an average of 1 year
AUC of the CyTOF-based immune model for detecting CIN3+ lesions in HPV16/18-positive women
Measured: 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
Measured: 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，
Measured: through study completion, an average of 1 year
AUC of the CyTOF-based immune model for detecting CIN2+ lesions in HPV16/18-positive women
Measured: 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
Measured: 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)
Measured: 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)
Measured: through study completion, an average of 1 year
Compare the CyTOF-based immune model's negative predictive values with those of conventional screening methods (including cytology, HPV genotyping, and colposcopy-directed cervical biopsy)
Measured: through study completion, an average of 1 year
AUC of the CyTOF-based immune model for detecting CIN3+ lesions across subgroups(e.g., by age group and vaccination status)
Measured: through study completion, an average of 1 year
Calibration Slope of the CyTOF-based immune model for detecting CIN3+ lesions across subgroups (e.g., by age group and vaccination status)
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start15 May 2026 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CIN 2/3Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,465 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Jiaxing Maternity and Child Health Care Hospital, Ningbo Women & Children's Hospital, Zhejiang PuLuoTing Health Technology Co., Ltd.
- Responsible party
- Principal investigator, Wang Hui, Women's Hospital School Of Medicine Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07606677
- Sponsor's protocol ID
- IRB-20260080-R
- Status last verified
- May 2026
- First submitted
- 6 May 2026
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mass Cytometry-based Peripheral Blood Immune Model for Accurate Detection of Cervical Lesions in HPV16/18-positive Women: a Multicenter Study
- ClinicalTrials.gov ID
- NCT07606677
- Acronym / sponsor ID
- IRB-20260080-R
- Conditions
- CIN 2/3, Cervical Cancer (Early Detection)
- Keywords
- cervical cancer, Cervical Intraepithelial Neoplasia, HPV16/18, Mass cytometry, Immune model
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,465 participants (estimated)
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Jiaxing Maternity and Child Health Care Hospital, Ningbo Women & Children's Hospital, Zhejiang PuLuoTing Health Technology Co., Ltd.
- Study start
- 15 May 2026 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 26 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study aimed to validate the diagnostic efficacy of our previously established CyTOF-based immune model for identifying CIN3+ lesions (including CIN3 and cervical cancer) in a multicenter prospective cohort of HPV16/18-positive women. In addition, this study seeks to promote the standardized implementation of mass cytometry in cervical lesion triage, construct a non-invasive, high-throughput and high-accuracy immune diagnostic workflow, improve the diagnostic efficiency and precision management of HPV16/18-positive populations, and minimize unnecessary invasive examinations as well as patients' psychological burden. Ultimately, it is expected to advance the precision-oriented optimization of national cervical cancer prevention strategies. Meanwhile, the feasibility and clinical superiority of this model will be evaluated by comparing it with current mainstream screening modalities, such as cervical cytology, HPV genotyping and colposcopy-guided cervical biopsy, which lays a solid foundation for the subsequent development of related auxiliary diagnostic reagents and products.(1)Primary objective: To validate the diagnostic efficacy (sensitivity, specificity, area under the curve [AUC]) of the CyTOF-based immune model for detecting CIN3+ lesions in HPV16/18-positive women.(2)Secondary objective: To validate the diagnostic efficacy (sensitivity, specificity, AUC) of the CyTOF-based immune model for detecting CIN2+ lesions in HPV16/18-positive women, and to compare its accuracy, positive and negative predictive values with those of conventional screening methods (including cytology, HPV genotyping, and colposcopy-directed cervical biopsy). (3)Exploratory objective: To investigate the adaptability and stability of the model across different populations (e.g., by age group and vaccination status).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HPV16/18-positive patients
Key inclusion criteria (3 listed)
- Availability of cervical cytology results
- Consent to colposcopy and cervical biopsy
- Signed informed consent
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The diagnostic sensitivity of the CyTOF-based immune model for detecting CIN3+ lesions in HPV16/18-positive women
Time frame: through study completion, an average of 1 year
AUC of the CyTOF-based immune model for detecting CIN3+ lesions in HPV16/18-positive women
Time frame: 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
Time frame: through study completion, an average of 1 year
8 secondary outcomes
The diagnostic sensitivity of the CyTOF-based immune model for detecting CIN2+ lesions in HPV16/18-positive women，
Time frame: through study completion, an average of 1 year
AUC of the CyTOF-based immune model for detecting CIN2+ lesions in HPV16/18-positive women
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: through study completion, an average of 1 year
Compare the CyTOF-based immune model's negative predictive values with those of conventional screening methods (including cytology, HPV genotyping, and colposcopy-directed cervical biopsy)
Time frame: through study completion, an average of 1 year
AUC of the CyTOF-based immune model for detecting CIN3+ lesions across subgroups(e.g., by age group and vaccination status)
Time frame: through study completion, an average of 1 year
Calibration Slope of the CyTOF-based immune model for detecting CIN3+ lesions across subgroups (e.g., by age group and vaccination status)
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: No. 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.
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CIN 2/3
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of CIN 2/3 and Cervical Cancer (Early Detection), run by Women's Hospital School Of Medicine Zhejiang University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Junfen Xu (+86 13567147767, xjfzu@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The diagnostic sensitivity of the CyTOF-based immune model for detecting CIN3+ lesions in HPV16/18-positive women (time frame: through study completion, an average of 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.