CervIcal Cancer Screening Trial by Randomization of HPV Testing Intervention for Upcoming Screening （CITRUS Study）

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Cervical Cancer

Intervention / Treatment
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* Other: LBC
* Other: LBC plus HPV DNA testing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women aged 30-64 years old Participants provided written informed consent Exclusion Criteria: Women who will receive planed HPV DNA testing by local governmental cervical cancer program next six years have had cervical invasive cancer before have undergone cervical conization have undergone hysterectomy have had or have the cytological abnormalities and are under follow-up are pregnant are judged ineligible for this trial by physician

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LBC<br>Cervical cancer screening by using liquid based cytology as a standard screening modality | Other: LBC<br>* Cervical cancer screening by using liquid based cytology as a standard screening modality<br>|
| Experimental: LBC plus HPV DNA testing<br>Cervical cancer screening by using liquid based cytology plus HPV DNA testing as an experimentally screening modality | Other: LBC plus HPV DNA testing<br>* Cervical cancer screening by using liquid based cytology plus HPV DNA testing as an experimentally screening modality<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of cervical intraepithelial neoplasia(CIN)3 or worse during the whole period |  | 6 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of CIN3 or worse at baseline, and two years, four years, and six years post baseline |  | 2 years, 4 years, 6 years | 
| The incidence of CIN2 or worse at baseline, and two years, four years, and six years post baseline |  | 2 years, 4 years, 6 years | 
| The incidence of CIN1 or worse at baseline, and two years, four years, and six years post baseline |  | 2 years, 4 years, 6 years | 
| The incidence of invasive cancer at baseline, and two years, four years, and six years post baseline |  | 2 years, 4 years, 6 years | 
| The number of cervical cytology performance |  | 6 years | 
| The number of colposcopy and biopsy performance |  | 6 years |