TS Triage of HR-HPV Positive Population and Its Accuracy Study

N/AActive Not RecruitingNCT07777094

Affiliated Hospital of Nantong University300 enrolled

Overview

A prospective study assessing TS accuracy in HR-HPV+ women, influencing factors, and 1-year follow-up of false-positives versus biopsy.

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 Type

OBSERVATIONAL

Enrollment

300

Conditions

Cervical Precancerous Lesions Cervical Cancer

Interventions

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.

Eligibility

Sex: FEMALEHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. 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； 2. Informed consent obtained from voluntary participants. Exclusion Criteria: 1. Patients who are unable to cooperate or have poor compliance; 2. Within four months postpartum; 3. During the first three days of menstruation with heavy flow; 4. Within three months after cervical surgery (including cervical biopsy); 5. Previous radiotherapy in the pelvic region; 6. Currently undergoing chemotherapy or within five weeks after chemotherapy; 7. Clinically evident acute or subacute cervical/vaginal infection; 8. History of photosensitivity disorders, current photodynamic therapy, or exposure to photosensitizing agents; 9. 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); 10. Other patients deemed ineligible by the investigators.

Locations (1)

Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: January 2025 to December 2025

Negative predictive value of TS in populations with different HR-HPV subtypes and viral loads

Data from ClinicalTrials.gov

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Secondary Outcomes

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.

Time frame: 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.

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

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.

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

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.

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

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.

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

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.

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

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.

Time frame: Baseline (initial visit), 6-month follow-up, 12-month follow-up.