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

17. august 2026 opdateret af: Affiliated Hospital of Nantong University

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.

Studieoversigt

Status

Status

Angiver den aktuelle rekrutteringsstatus eller den udvidede adgangsstatus.
Aktiv, ikke rekrutterende

Betingelser

Betingelser

Den sygdom, lidelse, syndrom, sygdom eller skade, der undersøges. På ClinicalTrials.gov kan tilstande også omfatte andre sundhedsrelaterede problemer, såsom levetid, livskvalitet og sundhedsrisici.

Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.

Detaljeret beskrivelse

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.

Undersøgelsestype

Undersøgelsestype

Beskriver karakteren af ​​en klinisk undersøgelse. Undersøgelsestyper omfatter interventionelle undersøgelser (også kaldet kliniske forsøg), observationsundersøgelser (herunder patientregistre) og udvidet adgang.
Observationel

Tilmelding (Anslået)

Tilmelding

Antallet af deltagere i en klinisk undersøgelse. Den "forventede" tilmelding er det mål for antallet af deltagere, som forskerne skal bruge til undersøgelsen.
300

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Kina
    • Jiangsu
      • Nantong, Jiangsu, Kina, 226001
        • Affiliated Hospital of Nantong University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Berettigelseskriterier

De nøglekrav, som personer, der ønsker at deltage i et klinisk studie, skal opfylde eller de egenskaber, de skal have. Kvalifikationskriterier består af både inklusionskriterier (som er nødvendige for at en person kan deltage i undersøgelsen) og eksklusionskriterier (som forhindrer en person i at deltage). Typer af berettigelseskriterier omfatter, om en undersøgelse accepterer raske frivillige, har alders- eller aldersgruppekrav eller er begrænset af køn.

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte

Gruppe / kohorte

En gruppe eller undergruppe af deltagere i et observationsstudie, der vurderes for biomedicinske eller sundhedsmæssige resultater.
Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.
HPV16/18 - Low VL
HPV type 16/18 positive, low viral load group (1.00-99.99 RLU/PC)
Diagnostisk test: Colposcopy and cervical biopsy
The cervix was visualized through colposcopic magnification and samples of suspicious tissue were taken for pathological examination.
Diagnostisk test: Follow-up of TS false-positive patients
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.
HPV16/18 - Medium VL
HPV type 16/18 positive, medium viral load group (100-999.99 RLU/PC)
Diagnostisk test: Colposcopy and cervical biopsy
The cervix was visualized through colposcopic magnification and samples of suspicious tissue were taken for pathological examination.
Diagnostisk test: Follow-up of TS false-positive patients
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.
HPV16/18 - High VL
HPV type 16/18 positive, high viral load group (≥1000.00 RLU/PC)
Diagnostisk test: Colposcopy and cervical biopsy
The cervix was visualized through colposcopic magnification and samples of suspicious tissue were taken for pathological examination.
Diagnostisk test: Follow-up of TS false-positive patients
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.
Other12 HR-HPV - Low VL
Positive for 12 other high-risk HPV types, low viral load group (1.00-99.99 RLU/PC)
Diagnostisk test: Colposcopy and cervical biopsy
The cervix was visualized through colposcopic magnification and samples of suspicious tissue were taken for pathological examination.
Diagnostisk test: Follow-up of TS false-positive patients
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.
Other12 HR-HPV - Medium VL
Positive for 12 other high-risk HPV types, medium viral load group (100-999.99 RLU/PC)
Diagnostisk test: Colposcopy and cervical biopsy
The cervix was visualized through colposcopic magnification and samples of suspicious tissue were taken for pathological examination.
Diagnostisk test: Follow-up of TS false-positive patients
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.
Other12 HR-HPV - High VL
Positive for 12 other high-risk HPV types, high viral load group (≥1000.00 RLU/PC)
Diagnostisk test: Colposcopy and cervical biopsy
The cervix was visualized through colposcopic magnification and samples of suspicious tissue were taken for pathological examination.
Diagnostisk test: Follow-up of TS false-positive patients
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.

Hvad måler undersøgelsen?

Primære resultatmål

Primære resultatmål

I et klinisk studies protokol er det planlagte resultatmål, der er det vigtigste for at evaluere effekten af ​​en intervention/behandling. De fleste kliniske undersøgelser har ét primært resultatmål, men nogle har mere end ét.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Sensitivity of TS for diagnosing populations with different HR-HPV subtypes and viral loads
Tidsramme: 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.
January 2025 to December 2025
The specificity of TS in diagnosing individuals with different HR-HPV subtypes and viral loads
Tidsramme: 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.
January 2025 to December 2025
The positive predictive value of TS in populations with different HR-HPV subtypes and viral loads
Tidsramme: 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.
January 2025 to December 2025
Negative predictive value of TS in populations with different HR-HPV subtypes and viral loads
Tidsramme: 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.
January 2025 to December 2025
The AUC of TS in diagnosing individuals with different HR-HPV subtypes and viral loads
Tidsramme: 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.
January 2025 to December 2025

Sekundære resultatmål

Sekundære resultatmål

I en klinisk undersøgelses protokol er et planlagt resultatmål, der ikke er lige så vigtigt som det primære resultatmål for at evaluere effekten af ​​en intervention, men som stadig er af interesse. De fleste kliniske undersøgelser har mere end ét sekundært resultatmål.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Factors Contributing to False-Positive Results in TS
Tidsramme: January 2025 to December 2025
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.
January 2025 to December 2025
Factors Contributing to False-Negative Results in TS
Tidsramme: January 2025 to December 2025
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.
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
Tidsramme: Baseline (initial visit), 6-month follow-up, 12-month follow-up.
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.
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
Tidsramme: Baseline (initial visit), 6-month follow-up, 12-month follow-up.
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.
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
Tidsramme: Baseline (initial visit), 6-month follow-up, 12-month follow-up.
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.
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
Tidsramme: Baseline (initial visit), 6-month follow-up, 12-month follow-up.
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.
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
Tidsramme: Baseline (initial visit), 6-month follow-up, 12-month follow-up.
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.
Baseline (initial visit), 6-month follow-up, 12-month follow-up.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sponsor

Den organisation eller person, der igangsætter undersøgelsen, og som har myndighed og kontrol over undersøgelsen.
Affiliated Hospital of Nantong University

Efterforskere

Efterforskere

En forsker involveret i et klinisk studie. Beslægtede termer omfatter stedets principal investigator, site sub-investigator, studieformand, undersøgelsesleder og undersøgelseshovedinvestigator.
  • Ledende efterforsker: Yuquan Zhang Professor, Affiliated Hospital of Nantong University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

Studiestart

Den faktiske dato, hvor den første deltager blev tilmeldt en klinisk undersøgelse. Den "forventede" undersøgelses startdato er den dato, som forskerne tror vil være undersøgelsens startdato.
1. oktober 2024

Primær færdiggørelse (Anslået)

Primær færdiggørelse

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention for at indsamle endelige data for det primære resultatmål. Hvorvidt det kliniske studie sluttede i henhold til protokollen eller blev afsluttet, påvirker ikke denne dato. For kliniske undersøgelser med mere end ét primært resultatmål med forskellige afslutningsdatoer refererer dette udtryk til den dato, hvor dataindsamlingen er afsluttet for alle de primære resultatmål. Den "forventede" primære afslutningsdato er den dato, som forskerne tror vil være den primære afslutningsdato for undersøgelsen.
31. december 2027

Studieafslutning (Anslået)

Studieafslutning

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention/behandling for at indsamle endelige data for de primære resultatmål, sekundære udfaldsmål og uønskede hændelser (det vil sige den sidste deltagers sidste besøg). Den "forventede" undersøgelses afslutningsdato er den dato, som forskerne tror vil være undersøgelsens afslutningsdato.
31. december 2027

Datoer for studieregistrering

Først indsendt

Først indsendt

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsendte en undersøgelsespost til ClinicalTrials.gov. Der er typisk en forsinkelse på et par dage mellem den første indsendte dato og postens tilgængelighed på ClinicalTrials.gov (den første offentliggjorte dato).
17. august 2026

Først indsendt, der opfyldte QC-kriterier

Først indsendt, der opfyldte QC-kriterier

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsender en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Sponsoren eller investigatoren skal muligvis revidere og indsende en undersøgelsespost en eller flere gange, før NLM's kvalitetskontrolkriterier er opfyldt. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
17. august 2026

Først opslået (Faktiske)

Først opslået

Datoen, hvor undersøgelsesposten først var tilgængelig på ClinicalTrials.gov efter National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgang er afsluttet. Der er typisk en forsinkelse på et par dage mellem den dato, hvor undersøgelsens sponsor eller investigator indsendte undersøgelsesposten, og den første offentliggjorte dato.
20. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering sendt

Den seneste dato, hvor ændringer i en undersøgelsespost blev gjort tilgængelig på ClinicalTrials.gov. Der kan være en forsinkelse mellem det tidspunkt, hvornår ændringerne blev indsendt til ClinicalTrials.gov af undersøgelsens sponsor eller investigator (datoen for sidste opdatering afsendt) og den sidste opdatering, der blev sendt.
20. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Den seneste dato, hvor undersøgelsens sponsor eller investigator indsendte ændringer til en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
17. august 2026

Sidst verificeret

Sidst verificeret

Den seneste dato, hvor undersøgelsens sponsor eller investigator bekræftede oplysningerne om en klinisk undersøgelse på ClinicalTrials.gov som nøjagtige og aktuelle. Hvis en undersøgelse med rekrutteringsstatus som rekruttering; rekrutterer endnu ikke; eller aktiv, ikke rekruttering er ikke blevet bekræftet inden for de seneste 2 år, er undersøgelsens rekrutteringsstatus vist som ukendt.
1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Andre undersøgelses-id-numre

Andre identifikatorer eller ID-numre end NCT-nummeret, der er tildelt til en klinisk undersøgelse af undersøgelsens sponsor, finansieringsgivere eller andre. Disse numre kan omfatte unikke identifikatorer fra andre forsøgsregistre og National Institutes of Health-bevillingsnumre.
  • Tdfy-FCK-2025

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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