MIA-COMP Pivotal Study: COMParative Self-Collection for Cervical Cancer Screening
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 260
- 试验地点
- 11
- 主要终点
- Rate of SAEs
研究概览
简要总结
To evaluate whether individuals drawn from the intended use population can successfully interpret and follow the IFU for the Mia by XytoTest self-collection device and perform a vaginal sample collection yielding sufficient cellular material for primary hrHPV screening.
To assess the clinical performance of Mia self-collected vaginal specimens by evaluating agreement with paired clinician-collected cervical specimens for the detection of high-risk HPV, when both specimen types are analyzed using the cobas HPV Test (Roche Molecular Systems). Residual samples may be used to determine adequacy for additional assays that require vaginal and/or cervical specimens (such as mRNA E6 and E7 Biomarker Test, dual stain cytology).
详细描述
The purpose of this pivotal study is to generate the clinical evidence necessary to support FDA marketing authorization for the Mia device. Specifically, the study will evaluate the diagnostic agreement of Mia-collected self-samples against the standard of care clinician-collected method for primary hrHPV detection, confirm device safety, demonstrate that end users across a diverse population can use the device safely and effectively as directed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 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
- •Group 1: General Population Group
- •Participants are 25 to 65 years of age and willing to provide informed consent.
- •Participants have an intact cervix.
- •Group 2: Enriched Population Group
- •Participants are 25 to 65 years of age and willing to provide informed consent.
- •Participants have an intact cervix.
- •One or more of: prior diagnosis of hrHPV within previous 6 months; abnormal cervical Pap cytology result of HSIL or higher (HSIL, AIS, or invasive carcinoma per the Bethesda 2014 system) within previous 6 months; and/or presenting for colposcopy/LEEP/excisional intervention.
排除标准
- •Apply to all groups:
- •Impaired decision-making capacity or inability to provide informed consent.
- •History of partial or total hysterectomy, including removal of the cervix.
- •Cervical tissue alteration or surgery within 5 months prior (conization, LEEP, laser ablation, or cryotherapy).
- •Current pregnancy (based on self-reporting).
- •Active menstruation at time of specimen collection.
- •Vaginal bleeding within 48 hours.
- •Have had sex or used tampons, creams, or other vaginal products in the last 48 hours.
- •Participation in another clinical study that, in the investigator's opinion, would interfere with the results of this study.
- •Any medical reason that, in the investigator's opinion, would disqualify the participant for a routine pelvic exam with cervical sample collection.
研究组 & 干预措施
General Population Group
- Participants are 25 to 65 years of age and willing to provide informed consent.
- Participants have an intact cervix.
干预措施: Mia by XytoTest (Diagnostic Test)
General Population Group
- Participants are 25 to 65 years of age and willing to provide informed consent.
- Participants have an intact cervix.
干预措施: Rovers Cervex-Brush (Diagnostic Test)
Enriched Population Group
- Participants are 25 to 65 years of age and willing to provide informed consent.
- Participants have an intact cervix.
- One or more of: prior diagnosis of hrHPV within previous 6 months; abnormal cervical Pap cytology result of HSIL or higher (HSIL, AIS, or invasive carcinoma per the Bethesda 2014 system) within previous 6 months; and/or presenting for colposcopy/LEEP/excisional intervention.
干预措施: Mia by XytoTest (Diagnostic Test)
Enriched Population Group
- Participants are 25 to 65 years of age and willing to provide informed consent.
- Participants have an intact cervix.
- One or more of: prior diagnosis of hrHPV within previous 6 months; abnormal cervical Pap cytology result of HSIL or higher (HSIL, AIS, or invasive carcinoma per the Bethesda 2014 system) within previous 6 months; and/or presenting for colposcopy/LEEP/excisional intervention.
干预措施: Rovers Cervex-Brush (Diagnostic Test)
结局指标
主要结局
Rate of SAEs
时间窗: Between 6 and 14 days.
Rate of self-collection using Mia as compared to rate of SAEs from clinician-collection.
NPA and PPA
时间窗: Within one week of sample collection.
Concordance between self-collected and physician-collected samples.
次要结局
未报告次要终点