Performance of Tampons as a Biospecimen Collection Tool for the Detection of Human Papillomavirus in a Colposcopy Setting
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 250
- 主要终点
- Sensitivity and specificity (%) of the tampon-assay combination & LBC assay combination for detection of histologically high grade disease
研究概览
简要总结
Evaluation of the clinical performance of the Daye Diagnostic Tampon (DDT) for the detection of Human Papilloma Virus (HPV) infection associated with high grade cervical disease. Cross sectional design with comparison to a clinician taken biospecimen. Performance will be measured relative to the presence/absence of histologically confirmed disease
详细描述
Type of Study: Clinical Trial
Goal: The goal of this clinical trial is to evaluate the clinical performance of the Daye Diagnostic Tampon (DDT) for the detection of HPV infection associated with high-grade cervical disease.
Main Questions:
What is the sensitivity and specificity of molecular HPV assays in detecting high-grade cervical disease (CIN2+) using the DDT compared to a clinician-taken, liquid-based cytology (LBC) sample?
How does the relative sensitivity and specificity of HPV detection in the tampon compare to the LBC sample for the detection of CIN2+?
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Individuals aged 25-65 years (inclusive)
- •Ability to understand patient information sheet
- •Ability to provide informed consent
- •Natal female
- •Referred to colposcopy for routine indications
- •In-tact cervix
排除标准
- •<25 years of age or over 65 years of age
- •Hysterectomised
- •Known allergy or sensitivity to tampons
- •Pregnancy (current) or within last 3 months
- •History of toxic shock syndrome
- •Concurrent participation in other interventional research project
结局指标
主要结局
Sensitivity and specificity (%) of the tampon-assay combination & LBC assay combination for detection of histologically high grade disease
时间窗: end of study (12 months from start)
To assess the sensitivity and specificity of molecular HPV assays for the detection of high grade cervical disease (defined as cervical intraepithelial neoplasia grade 2 or worse, CIN2+) using the DDT AND a clinician taken, liquid based cytology (LBC) sample
Relative sensitivity of the tampon-assay combination vs the LBC-assay combination
时间窗: end of study (12 months from start)
To determine the relative sensitivity and specificity of HPV detection in the tampon vs the LBC sample for the detection of CIN2+.
次要结局
- Attitudes to using the Diagnostic Tampon(up to 24 weeks)
- Assessment of Participation Willingness in Research on Tampon-Based Microbial Testing Among Colposcopy Patients(up to 24 weeks)