Clinical trial · Observational
Accurate Screening and Prevention of Cervical Lesions-- Development of Accurate Screening Methods for Cervical Lesions
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this observational study is to compare the accuracy and sensitivity of High-throughput human papilloma virus(HPV) typing and integrated assays with routine screening protocols (Cobas HPV test combined with thinprep cytologic test(TCT) for the detection of cervical intraepithelial neoplasia in the general and hospital populations. The main questions it aims to answer are: * High-throughput HPV typing and integrated assays can screen for ≥ cervical intraepithelial neoplasia (CIN2 or CIN3) with high sensitivity and accuracy. * High-throughput HPV typing and integrated assays can be promoted as a screening tool for cervical cancer. Participants will be screened with routine screening protocols (Cobas HPV test combined with TCT test), and if the results are abnormal, colposcopy and cervical biopsy will be performed.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Intraepithelial Neoplasia Grade 2/3 | Cervical Intraepithelial Neoplasia Grade 2/3 | ONTOLOGY_EXACT | 0.98 |
| Cervical Lesion | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cobas HPV test | Diagnostic Test | — | UNRESOLVED |
| High throughput HPV typing and integration detection methods | Diagnostic Test | — | UNRESOLVED |
| TCT test | Diagnostic Test | — | UNRESOLVED |
| Vaginoscopy | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- 1. Stratified experimental design
- description
- Relying on the project's clinical multicenter to recruit patients for routine HPV screening in hospital outpatient clinics, for HPV high-risk type-positive subjects. The subjects with positive HPV types will continue to undergo TCT and colposcopic biopsy, and the remaining specimens after routine screening will be collected for high-throughput HPV typing and integrated assays. The sensitivity and accuracy of high-throughput HPV typing and integrated assays were compared with conventional screening methods.
- interventionNames
- Diagnostic Test: TCT test
- Diagnostic Test: Vaginoscopy
- Diagnostic Test: High throughput HPV typing and integration detection methods
- Diagnostic Test: Cobas HPV test
- label
- 2. Parallel experimental design
- description
- A multicenter cohort of 12,000 permanent residents was recruited for routine cervical cancer screening(HPV+TCT combined screening), and the remaining specimens were collected after the conventional screening to test the indexes of high-throughput HPV typing and integrated assays. The sensitivity and accuracy of high-throughput HPV typing and integrated assays were compared with conventional screening methods.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. First screening. 2. History of sexual intercourse. Exclusion Criteria: 1. Previous CIN, cervical cancer or other cervical lesions; 2. History of cervical treatment; 3. Age \<25, \>70 years; 4. Pregnancy.
References
Publications (0)
Data not yet available