ChiCTR2300070427Not yet recruiting诊断试验新技术临床试验
HPV E6/E7 mRNA 检测应用于宫颈癌精准筛查的多中心研究
郑州科蒂亚生物技术有限公司4 sites in 1 countryStarted: April 1, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- 诊断试验新技术临床试验
- Status
- Not yet recruiting
- Sponsor
- Locations
- 4
- Primary Endpoint
- HPV E6/E7 mRNA
Study Overview
Brief Summary
评估 HPV E6/E7 mRNA 检测应用于宫颈癌精准筛查的准确性。
Study Design
- Study Type
- 诊断试验
- Primary Purpose
- 横断面
Eligibility Criteria
- Ages
- 21 to 59 (—)
- Sex
- Female
Inclusion Criteria
- •1.TCT 和 / 或 HPV 异常需行阴道镜检查的妇科患者,年龄 21-59 周岁;
Exclusion Criteria
- •有盆腔放化疗史、曾做过宫颈手术或全子宫切除术者;
- •妊娠期或产后 8 周及以内的女性;
Outcomes
Primary Outcomes
HPV E6/E7 mRNA
病理结果
准确度
灵敏度
特异度
Secondary Outcomes
- seq HPV
Investigators
Study Sites (4)
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