Cervical Precancerous LesionsNCT07777094
TS Triage of HR-HPV Positive Population and Its Accuracy Study
An observational study of Cervical Precancerous Lesions and Cervical Cancer, run by Affiliated Hospital of Nantong University at 1 site in China.
Trial summary
A prospective study assessing TS accuracy in HR-HPV+ women, influencing factors, and 1-year follow-up of false-positives versus biopsy. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Precancerous Lesions, Cervical Cancer
- What is being tested?
- Colposcopy and cervical biopsy and Follow-up of TS false-positive patients
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2024to 31 Dec 2027
- How long will I take part?
- 1 Year
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients who visited the gynecological outpatient department of the Affiliated Hospital of Nantong University between October 2024 and October 2026, and were detected as positive for high-risk human papillomavirus (HR-HPV) in cervical cancer screening through the Hybrid Capture 2 (HC2) technique, and had indications for colposcopic evaluation, and were scheduled for colposcopy or cervical pathological biopsy, as well as those patients who had both the HPV viral load test results and the Triple Staining (TS) results in our hospital and were awaiting colposcopy, will be selected.
Who may be able to join
- Patients in our outpatient clinic who have already undergone HPV viral load testing and are awaiting colposcopy, or those who have both HPV viral load test results and TS (Triple Staining) results and are awaiting colposcopy；
- Informed consent obtained from voluntary participants.
Who cannot join
- Patients who are unable to cooperate or have poor compliance;
- Within four months postpartum;
- During the first three days of menstruation with heavy flow;
- Within three months after cervical surgery (including cervical biopsy);
- Previous radiotherapy in the pelvic region;
- Currently undergoing chemotherapy or within five weeks after chemotherapy;
Show all 10Show fewer
- Clinically evident acute or subacute cervical/vaginal infection;
- History of photosensitivity disorders, current photodynamic therapy, or exposure to photosensitizing agents;
- Suspected or confirmed history of alcohol/drug abuse, or any other condition that-in the investigator's judgment-may reduce enrollment feasibility or complicate participation (e.g., frequent job relocation, unstable living conditions leading to high risk of loss to follow-up);
- Other patients deemed ineligible by the investigators.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study on the Application of TS for Triage in HR-HPV Viral Load Positive Population and Accuracy Related Studies
A prospective study assessing TS accuracy in HR-HPV+ women, influencing factors, and 1-year follow-up of false-positives versus biopsy.
Read the detailed description
The study will be conducted between 2025.01 and 2027.12 and will assess the diagnostic accuracy of TS testing in patients with positive HR-HPV viral loads by means of a prospective controlled study analyzing the factors influencing the false positive/negative results (age/gynecological findings/vaginal microbiota, etc.) and using cervical biopsy as a reference standard for 1 year in cases of TS false positives. The principal investigator will write and publish a paper.
- Conditions
- Cervical Precancerous Lesions, Cervical Cancer
- Being tested
- Colposcopy and cervical biopsy, Follow-up of TS false-positive patients
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colposcopy and cervical biopsyDiagnostic test
The cervix was visualized through colposcopic magnification and samples of suspicious tissue were taken for pathological examination.
Follow-up of TS false-positive patientsDiagnostic test
False-positive people with initial TS screening were followed up for 1 year, with a second TS examination six months after the initial TS screening.
| Study group | Role | What they receive |
|---|---|---|
| HPV16/18 - Low VL | HPV type 16/18 positive, low viral load group (1.00-99.99 RLU/PC) Receives: Diagnostic Test: Colposcopy and cervical biopsy; Diagnostic Test: Follow-up of TS false-positive patients | |
| HPV16/18 - Medium VL | HPV type 16/18 positive, medium viral load group (100-999.99 RLU/PC) Receives: Diagnostic Test: Colposcopy and cervical biopsy; Diagnostic Test: Follow-up of TS false-positive patients | |
| HPV16/18 - High VL | HPV type 16/18 positive, high viral load group (≥1000.00 RLU/PC) Receives: Diagnostic Test: Colposcopy and cervical biopsy; Diagnostic Test: Follow-up of TS false-positive patients | |
| Other12 HR-HPV - Low VL | Positive for 12 other high-risk HPV types, low viral load group (1.00-99.99 RLU/PC) Receives: Diagnostic Test: Colposcopy and cervical biopsy; Diagnostic Test: Follow-up of TS false-positive patients | |
| Other12 HR-HPV - Medium VL | Positive for 12 other high-risk HPV types, medium viral load group (100-999.99 RLU/PC) Receives: Diagnostic Test: Colposcopy and cervical biopsy; Diagnostic Test: Follow-up of TS false-positive patients | |
| Other12 HR-HPV - High VL | Positive for 12 other high-risk HPV types, high viral load group (≥1000.00 RLU/PC) Receives: Diagnostic Test: Colposcopy and cervical biopsy; Diagnostic Test: Follow-up of TS false-positive patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of TS for diagnosing populations with different HR-HPV subtypes and viral loads
Using cervical biopsy pathology as the gold standard, the study participants were stratified into 6 detailed subgroups based on HR-HPV genotype (HPV 16/18 and other 12 genotypes) and viral load gradients (low: 1.00-99.99; medium: 100-999.99; high: ≥1000.00) to form six detailed subgroups. The percentage of TS-positive cases among pathologically confirmed patients was calculated for each subgroup to determine the differences in diagnostic sensitivity when using TS as a screening tool.
Measured: January 2025 to December 2025
The specificity of TS in diagnosing individuals with different HR-HPV subtypes and viral loads
Using the pathological diagnosis of cervical biopsy as the gold standard, the study subjects were stratified into 6 detailed subgroups based on HR-HPV genotype (HPV 16/18 and other 12 genotypes) and viral load gradients (low: 1.00-99.99; medium: 100-999.99; high: ≥1000.00) to form six detailed subgroups. The percentage of TS-negative cases among pathologically negative (non-lesional) patients was calculated for each subgroup to clarify the differences in clinical efficacy of the test as a triage tool in excluding non-lesional individuals and reducing unnecessary referral rates.
Measured: January 2025 to December 2025
The positive predictive value of TS in populations with different HR-HPV subtypes and viral loads
Using cervical biopsy pathology as the gold standard, the study participants were stratified into 6 detailed subgroups based on HR-HPV genotype (HPV 16/18 and other 12 genotypes) and viral load gradients (low: 1.00-99.99; medium: 100-999.99; high: ≥1000.00) to form six detailed subgroups. The percentage of TS-positive subjects in each subgroup who were pathologically confirmed to have lesions was calculated to assess the predictive ability of TS-positive results for cervical high-grade lesions and their clinical diagnostic value across different viral load levels.
Measured: January 2025 to December 2025
Negative predictive value of TS in populations with different HR-HPV subtypes and viral loads
Using cervical biopsy pathology as the gold standard, the study participants were stratified into 6 detailed subgroups based on HR-HPV genotype (HPV 16/18 and other 12 genotypes) and viral load gradients (low: 1.00-99.99; medium: 100-999.99; high: ≥1000.00) to form six detailed subgroups. The percentage of subjects with a normal/non-lesional pathological diagnosis among those with a negative TS test result was calculated for each subgroup to assess the reliability of TS-negative results in ruling out cervical lesions and to determine the safety of using TS as a triage tool at different viral load levels.
Measured: January 2025 to December 2025
The AUC of TS in diagnosing individuals with different HR-HPV subtypes and viral loads
Using the pathological diagnosis of cervical biopsy as the gold standard, the study subjects were stratified into 6 detailed subgroups based on HR-HPV genotyping (HPV types 16/18 and other 12 types) and viral load gradients (low: 1.00-99.99; medium: 100-999.99; high: ≥1000.00) to form six detailed subgroups. By plotting receiver operating characteristic (ROC) curves and calculating the area under the curve (AUC), we comprehensively evaluated the overall diagnostic performance of TS in distinguishing between women with and without cervical lesions across different viral load levels. The closer the AUC value is to 1.0, the higher the accuracy of TS in classifying patients within that subgroup.
Measured: January 2025 to December 2025
Secondary outcomes (7)
Factors Contributing to False-Positive Results in TS
This study used pathological diagnosis based on cervical biopsy as the gold standard. Patients with positive TS test results but pathological diagnoses of normal or inflammation were defined as the TS false-positive group, while the TS true-positive group-in which TS and pathological results were consistent-served as the control group. Univariate and multivariate logistic regression analyses were performed on the two groups, examining factors such as age, cervical conditions (e.g., columnar epithelium ectopia, hypertrophy, polyps), history of cervical conization, and vaginal microbiome (various types of vaginal inflammation and pathogen infections), with the aim of identifying independent risk factors contributing to false-positive interference in TS results.
Measured: January 2025 to December 2025
Factors Contributing to False-Negative Results in TS
This study used the pathological diagnosis of cervical biopsy as the gold standard, defining patients with negative TS test results but a pathological diagnosis of lesions as the TS false-negative group, and using the TS true-negative group-in which TS and pathological results were consistent-as the control group. Through univariate and multivariate logistic regression analyses of indicators such as age, cervical anatomical status, and vaginal microbiome composition in both patient groups, the study aims to identify independent risk factors leading to TS missed diagnosis (false negatives) and provide clinical evidence to optimize screening strategies.
Measured: January 2025 to December 2025
Sensitivity of TS in predicting 1-year follow-up outcomes in patients with a positive initial screening result but a negative cervical biopsy
This indicator uses the pathological diagnoses from the second and third cervical biopsies during the 1-year follow-up period as the gold standard. For the specific population of patients who were "TS-positive but biopsy-negative" at the initial visit, it calculates the percentage of patients in this group who tested positive on subsequent TS screening during the follow-up period out of the total number of patients in this group who were ultimately pathologically confirmed to have lesions. This indicator is designed to evaluate the ability of TS to detect missed diagnoses at the initial visit, occult lesions, or newly developed lesions during long-term monitoring, to clarify its safety as a follow-up management tool, and to prevent the missed diagnosis of high-grade lesions.
Measured: Baseline (initial visit), 6-month follow-up, 12-month follow-up.
Specificity of TS in predicting 1-year follow-up outcomes for patients with a positive initial screening result but a negative cervical biopsy
This indicator uses the pathological diagnoses from the second and third cervical biopsies during a 1-year follow-up period as the gold standard. For a specific subgroup of patients who were "TS-positive but biopsy-negative" at their initial visit, it calculates the percentage of patients in this subgroup who maintained a consistently negative TS result during follow-up, relative to the total number of patients in this subgroup who ultimately maintained a normal or inflammatory pathological diagnosis. This indicator aims to evaluate the ability of TS to rule out transient risks and identify non-lesional cases, thereby demonstrating its clinical efficacy in reducing unnecessary repeat biopsies and optimizing the allocation of medical resources during the follow-up process.
Measured: Baseline (initial visit), 6-month follow-up, 12-month follow-up.
The positive predictive value of TS for predicting outcomes at 1-year follow-up in patients with a positive initial screening result but a negative cervical biopsy
This indicator uses the pathological diagnoses from the second and third cervical biopsies during the 1-year follow-up period as the gold standard. For the specific subgroup of patients who were "TS-positive but biopsy-negative" at the initial visit, it calculates the percentage of patients among all those with positive TS results during follow-up who were ultimately pathologically confirmed to have lesions. This indicator aims to evaluate the predictive value of TS "false-positive" results in identifying actual lesions during follow-up, thereby providing data to support clinical decisions regarding the timing of intervention.
Measured: Baseline (initial visit), 6-month follow-up, 12-month follow-up.
The negative predictive value of TS for predicting outcomes at 1-year follow-up in patients with a positive initial screening result but a negative cervical biopsy
This indicator uses the pathological diagnoses from the second and third cervical biopsies during the 1-year follow-up period as the gold standard. For the specific subgroup of patients who were "TS-positive but biopsy-negative" at the initial visit, it calculates the percentage of patients who maintained a normal/negative pathological result throughout the follow-up period among those with negative TS results on all follow-up tests. This indicator is used to evaluate the safety of TS-negative results in follow-up management, providing a basis for using it as a decision-making tool to extend follow-up intervals and reduce monitoring frequency.
Measured: Baseline (initial visit), 6-month follow-up, 12-month follow-up.
The AUC of TS for predicting 1-year follow-up outcomes in patients with a positive initial screening result but a negative cervical biopsy
This metric uses the pathological diagnoses from the second and third cervical biopsies during the 1-year follow-up period as the gold standard. For the specific subgroup of patients who were "TS-positive but biopsy-negative" at the initial visit, a ROC curve is plotted and the area under the curve (AUC) is calculated by integrating dynamic testing data collected over the 1-year follow-up period. This indicator aims to comprehensively evaluate the overall predictive accuracy of TS regarding long-term disease outcomes in this population and to compare the monitoring efficacy of TS alone versus TS combined with HPV testing.
Measured: Baseline (initial visit), 6-month follow-up, 12-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start1 Oct 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Precancerous LesionsStudies of the same condition, open and under way.
- More trials run by Affiliated Hospital of Nantong UniversityThe sponsor's other registered studies.
- 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
- 300 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Nantong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yuquan Zhang Professor, Principal investigator, Affiliated Hospital of Nantong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07777094
- Sponsor's protocol ID
- Tdfy-FCK-2025
- Status last verified
- Aug 2026
- First submitted
- 17 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Application of TS for Triage in HR-HPV Viral Load Positive Population and Accuracy Related Studies
- ClinicalTrials.gov ID
- NCT07777094
- Acronym / sponsor ID
- Tdfy-FCK-2025
- Conditions
- Cervical Precancerous Lesions, Cervical Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Nantong UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 Aug 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.
A prospective study assessing TS accuracy in HR-HPV+ women, influencing factors, and 1-year follow-up of false-positives versus biopsy.
Detailed description
The study will be conducted between 2025.01 and 2027.12 and will assess the diagnostic accuracy of TS testing in patients with positive HR-HPV viral loads by means of a prospective controlled study analyzing the factors influencing the false positive/negative results (age/gynecological findings/vaginal microbiota, etc.) and using cervical biopsy as a reference standard for 1 year in cases of TS false positives. The principal investigator will write and publish a paper.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| HPV16/18 - Low VL | – | Diagnostic Test: Colposcopy and cervical biopsy, Diagnostic Test: Follow-up of TS false-positive patientsHPV type 16/18 positive, low viral load group (1.00-99.99 RLU/PC) |
| HPV16/18 - Medium VL | – | Diagnostic Test: Colposcopy and cervical biopsy, Diagnostic Test: Follow-up of TS false-positive patientsHPV type 16/18 positive, medium viral load group (100-999.99 RLU/PC) |
| HPV16/18 - High VL | – | Diagnostic Test: Colposcopy and cervical biopsy, Diagnostic Test: Follow-up of TS false-positive patientsHPV type 16/18 positive, high viral load group (≥1000.00 RLU/PC) |
| Other12 HR-HPV - Low VL | – | Diagnostic Test: Colposcopy and cervical biopsy, Diagnostic Test: Follow-up of TS false-positive patientsPositive for 12 other high-risk HPV types, low viral load group (1.00-99.99 RLU/PC) |
| Other12 HR-HPV - Medium VL | – | Diagnostic Test: Colposcopy and cervical biopsy, Diagnostic Test: Follow-up of TS false-positive patientsPositive for 12 other high-risk HPV types, medium viral load group (100-999.99 RLU/PC) |
| Other12 HR-HPV - High VL | – | Diagnostic Test: Colposcopy and cervical biopsy, Diagnostic Test: Follow-up of TS false-positive patientsPositive for 12 other high-risk HPV types, high viral load group (≥1000.00 RLU/PC) |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who visited the gynecological outpatient department of the Affiliated Hospital of Nantong University between October 2024 and October 2026, and were detected as positive for high-risk human papillomavirus (HR-HPV) in cervical cancer screening through the Hybrid Capture 2 (HC2) technique, and had indications for colposcopic evaluation, and were scheduled for colposcopy or cervical pathological biopsy, as well as those patients who had both the HPV viral load test results and the Triple Staining (TS) results in our hospital and were awaiting colposcopy, will be selected.
Key inclusion criteria (2 listed)
- Patients in our outpatient clinic who have already undergone HPV viral load testing and are awaiting colposcopy, or those who have both HPV viral load test results and TS (Triple Staining) results and are awaiting colposcopy；
- Informed consent obtained from voluntary participants.
Key exclusion criteria (10 listed)
- Patients who are unable to cooperate or have poor compliance;
- Within four months postpartum;
- During the first three days of menstruation with heavy flow;
- Within three months after cervical surgery (including cervical biopsy);
- Previous radiotherapy in the pelvic region;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colposcopy and cervical biopsyThe cervix was visualized through colposcopic magnification and samples of suspicious tissue were taken for pathological examination. | Diagnostic test | HPV16/18 - High VL, HPV16/18 - Low VL, HPV16/18 - Medium VL, Other12 HR-HPV - High VL, Other12 HR-HPV - Low VL, Other12 HR-HPV - Medium VL |
| Follow-up of TS false-positive patientsFalse-positive people with initial TS screening were followed up for 1 year, with a second TS examination six months after the initial TS screening. | Diagnostic test | HPV16/18 - High VL, HPV16/18 - Low VL, HPV16/18 - Medium VL, Other12 HR-HPV - High VL, Other12 HR-HPV - Low VL, Other12 HR-HPV - Medium VL |
Primary outcome
Sensitivity of TS for diagnosing populations with different HR-HPV subtypes and viral loads
Time frame: January 2025 to December 2025
Using cervical biopsy pathology as the gold standard, the study participants were stratified into 6 detailed subgroups based on HR-HPV genotype (HPV 16/18 and other 12 genotypes) and viral load gradients (low: 1.00-99.99; medium: 100-999.99; high: ≥1000.00) to form six detailed subgroups. The percentage of TS-positive cases among pathologically confirmed patients was calculated for each subgroup to determine the differences in diagnostic sensitivity when using TS as a screening tool.
The specificity of TS in diagnosing individuals with different HR-HPV subtypes and viral loads
Time frame: January 2025 to December 2025
Using the pathological diagnosis of cervical biopsy as the gold standard, the study subjects were stratified into 6 detailed subgroups based on HR-HPV genotype (HPV 16/18 and other 12 genotypes) and viral load gradients (low: 1.00-99.99; medium: 100-999.99; high: ≥1000.00) to form six detailed subgroups. The percentage of TS-negative cases among pathologically negative (non-lesional) patients was calculated for each subgroup to clarify the differences in clinical efficacy of the test as a triage tool in excluding non-lesional individuals and reducing unnecessary referral rates.
The positive predictive value of TS in populations with different HR-HPV subtypes and viral loads
Time frame: January 2025 to December 2025
Using cervical biopsy pathology as the gold standard, the study participants were stratified into 6 detailed subgroups based on HR-HPV genotype (HPV 16/18 and other 12 genotypes) and viral load gradients (low: 1.00-99.99; medium: 100-999.99; high: ≥1000.00) to form six detailed subgroups. The percentage of TS-positive subjects in each subgroup who were pathologically confirmed to have lesions was calculated to assess the predictive ability of TS-positive results for cervical high-grade lesions and their clinical diagnostic value across different viral load levels.
Negative predictive value of TS in populations with different HR-HPV subtypes and viral loads
Time frame: January 2025 to December 2025
Using cervical biopsy pathology as the gold standard, the study participants were stratified into 6 detailed subgroups based on HR-HPV genotype (HPV 16/18 and other 12 genotypes) and viral load gradients (low: 1.00-99.99; medium: 100-999.99; high: ≥1000.00) to form six detailed subgroups. The percentage of subjects with a normal/non-lesional pathological diagnosis among those with a negative TS test result was calculated for each subgroup to assess the reliability of TS-negative results in ruling out cervical lesions and to determine the safety of using TS as a triage tool at different viral load levels.
The AUC of TS in diagnosing individuals with different HR-HPV subtypes and viral loads
Time frame: January 2025 to December 2025
Using the pathological diagnosis of cervical biopsy as the gold standard, the study subjects were stratified into 6 detailed subgroups based on HR-HPV genotyping (HPV types 16/18 and other 12 types) and viral load gradients (low: 1.00-99.99; medium: 100-999.99; high: ≥1000.00) to form six detailed subgroups. By plotting receiver operating characteristic (ROC) curves and calculating the area under the curve (AUC), we comprehensively evaluated the overall diagnostic performance of TS in distinguishing between women with and without cervical lesions across different viral load levels. The closer the AUC value is to 1.0, the higher the accuracy of TS in classifying patients within that subgroup.
7 secondary outcomes
Factors Contributing to False-Positive Results in TS
Time frame: January 2025 to December 2025
Factors Contributing to False-Negative Results in TS
Time frame: January 2025 to December 2025
Sensitivity of TS in predicting 1-year follow-up outcomes in patients with a positive initial screening result but a negative cervical biopsy
Time frame: Baseline (initial visit), 6-month follow-up, 12-month follow-up.
Specificity of TS in predicting 1-year follow-up outcomes for patients with a positive initial screening result but a negative cervical biopsy
Time frame: Baseline (initial visit), 6-month follow-up, 12-month follow-up.
The positive predictive value of TS for predicting outcomes at 1-year follow-up in patients with a positive initial screening result but a negative cervical biopsy
Time frame: Baseline (initial visit), 6-month follow-up, 12-month follow-up.
The negative predictive value of TS for predicting outcomes at 1-year follow-up in patients with a positive initial screening result but a negative cervical biopsy
Time frame: Baseline (initial visit), 6-month follow-up, 12-month follow-up.
The AUC of TS for predicting 1-year follow-up outcomes in patients with a positive initial screening result but a negative cervical biopsy
Time frame: Baseline (initial visit), 6-month follow-up, 12-month follow-up.
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 20 Aug 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Yuquan Zhang Professor principal investigator
Affiliated Hospital of Nantong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Precancerous Lesions and Cervical Cancer, run by Affiliated Hospital of Nantong University at 1 site in China.
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 2 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of TS for diagnosing populations with different HR-HPV subtypes and viral loads (time frame: January 2025 to December 2025). The study lists 5 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 20 Aug 2026.