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Clinical Trials/ChiCTR2300070427
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

Sponsor
郑州科蒂亚生物技术有限公司

Study Sites (4)

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