NCT06676150尚未招募不适用
NCI Cervical Cancer 'Last Mile' Initiative 'Self-collection for HPV Testing to Improve Cervical Cancer Prevention
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Progression Free Survival
研究概览
简要总结
To look at the results from a sample collected for human papillomavirus (HPV) testing similar or the same as the results from the cervical sample collected by a doctor.
详细描述
Primary Objectives:
To evaulate clinical accuracy (including clinical sensitivity, clinical specificity, false positive rate, and false negative rate) for detection of cervical precancer/cancer and agreement/concordance (including positive percent agreement and negative percent agreement) on SC versus CC Samples for the following HPV genotype detections and groupings:
- Any HR HPV genotype
- HPV16
- Other individual HR HPV and/or assay-specific channels/pooled genotypes
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Willingness and ability to provide a documented informed consent.
- •Is 25 years of older.
- •Has an intact cervix.
- •Has had a referral for colposcpoy and/or cervical excisional procedure in which routine cervical cancer screening has included HPV testing (HPV primary screeing, co-testing, or ASC-US cytology triage) or abnormal cytology performed within the past 12 months preceding the referral visit.
- •Willing and able to undergo colposcopy, and if clinically indicated for SOC purposes, a biopsy, endocervical curettage, and/or cervical excisional procedure, as applicable.
- •Exclusion Criteria
- •An individiual meeting the following criteria will be ineligible for participation in the study:
- •Is pregnant when presenting for the referal visit or gave birth within the past three months.
- •Has known history of excisional or ablative therapy to the cervix (e.g., LEEP, cone biopsy, cervical laser surgery, cryotherpay, thermal ablation) in the last 12 months prior to the referral visit.
- •Has had a complete or partial hysterectomy, either supracervical or involving removal of the cervix, via self-report or confirmation via medical records.
- •Known medical conditions that, in the opinion of the investigator, prelude study participation.
- •Previous participation in the SHIP Trial. Participation is defined as completing the self-collection.
排除标准
- 未提供
结局指标
主要结局
Progression Free Survival
时间窗: Through study completion; an average of 1 year.
Progression Free Survival
次要结局
未报告次要终点
研究者
研究点 (1)
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