Clinical trial · Interventional
CervIcal Cancer Screening Trial by Randomization of HPV Testing Intervention for Upcoming Screening （CITRUS Study）
Randomized Controlled Trial to Evaluate the Efficacy of Concurrent Liquid-based Cytology ( LBC) and HPV DNA Testing Versus LBC Alone for the Primary Cervical Cancer Screening
NCT01895517CI-TRIAL-00067505completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- 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 aim of this study is to assess efficacy of the screening with concurrent liquid-based cytology and HPV DNA testing for the primary cervical cancer screening over 7 years.
Conditions
Conditions (1)
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 Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LBC | Other | — | UNRESOLVED |
| LBC plus HPV DNA testing | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- LBC
- description
- Cervical cancer screening by using liquid based cytology as a standard screening modality
- interventionNames
- Other: LBC
- type
- EXPERIMENTAL
- label
- LBC plus HPV DNA testing
- description
- Cervical cancer screening by using liquid based cytology plus HPV DNA testing as an experimentally screening modality
- interventionNames
- Other: LBC plus HPV DNA testing
Primary outcomes (1)
- measure
- The incidence of cervical intraepithelial neoplasia(CIN)3 or worse during the whole period
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 64 Years
Show eligibility criteria text
Inclusion Criteria: 1. Women aged 30-64 years old 2. Participants provided written informed consent Exclusion Criteria: Women who 1. will receive planed HPV DNA testing by local governmental cervical cancer program next six years 2. have had cervical invasive cancer before 3. have undergone cervical conization 4. have undergone hysterectomy 5. have had or have the cytological abnormalities and are under follow-up 6. are pregnant 7. are judged ineligible for this trial by physician
References
Publications (1)
- DERIVEDMorisada T, Teramoto K, Takano H, Sakamoto I, Nishio H, Iwata T, Hashi A, Katoh R, Okamoto A, Sasaki H, Nakatani E, Teramukai S, Aoki D. CITRUS, cervical cancer screening trial by randomization of HPV testing intervention for upcoming screening: Design, methods and baseline data of 18,471 women. Cancer Epidemiol. 2017 Oct;50(Pt A):60-67. doi: 10.1016/j.canep.2017.07.017. Epub 2017 Aug 16. PMID 28818742