NCI Cervical Cancer 'Last Mile' Initiative 'Self-Collection for HPV Testing to Improve Cervical Cancer Prevention' (SHIP) Trial LMI-001-A-S01
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 750
- 试验地点
- 15
- 主要终点
- Difference in FNR ratio between SC and CC samples (Group A)
研究概览
简要总结
This clinical trial evaluates the use of self-collected vaginal samples for human papillomavirus (HPV) testing in patients referred for a colposcopy and/or cervical excisional procedures to improve cervical cancer prevention. HPV is a common virus which usually causes infections that last only a few months, but sometimes can last longer. It is known to cause a variety of cancers including cancer of the cervix. Even though there are ways to detect cervical cancer early, many individuals do not undergo screening that involves pelvic exams. Over half of all new cervical cancer cases are among those who have either never been screened or who are not screened enough. Without appropriate screening and care, preventable pre-cancers may turn into cancer. A new way to detect cervical cancer is to have individuals collect their own vaginal sample for HPV testing to know their risk for cervical cancer. This may give individuals more flexibility and comfort having the ability to collect samples themselves, compared to a doctor performing a speculum examination and collecting the samples in a clinic. This study compares clinical accuracy of HPV testing on self-collected vaginal samples versus cervical samples collected by clinician.
The Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial is part of the National Cancer Institute (NCI)'s Cervical Cancer 'Last Mile' Initiative, a public private partnership that seeks to increase access to cervical cancer screening. The SHIP Trial focuses on developing clinical evidence to inform the US Food and Drug Administration (FDA)'s regulatory reviews of self-collection approaches as alternative sample collection approaches for cervical cancer screening. Several industry partner-specific self-collection device and assay combinations will be non-competitively and independently evaluated with a similar study design framework to inform pre-approval and/or post-approval regulatory requirements.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate clinical accuracy (including clinical sensitivity, clinical specificity, false positive rate, and false negative rate) for the detection of cervical precancer/cancer and agreement/concordance (including positive percent agreement and negative percent agreement) on self-collected (SC) versus clinician collected (CC) samples for the following HPV genotype detections and groupings by Becton, Dickinson and Company (BD) Onclarity (trademark) HPV assay: Any high risk (HR) HPV genotype, HPV16, HPV18, HPV31, HPV45, HPV51, HPV52, HPV33/58, HPV35/39/68, HPV56/59/66, HPV16 and/or HPV18, other 12 HR-HPV types (grouped). (Group A) II. To conduct an observational study among women attending regular cervical cancer screening ("intended use population" for the at-home collection indication). (Group B)
EXPLORATORY OBJECTIVES:
I. To evaluate human factors affecting usability, acceptability, and preferences for self-collection. (Group A) II. To evaluate agreement/concordance (including positive percent agreement and negative percent agreement) on SC versus CC samples for the following HPV genotype detections and groupings by BD Onclarity™ HPV assay: Any HR HPV genotype, HPV16, HPV18, HPV31, HPV45, HPV51, HPV52, HPV33/58, HPV35/39/68, HPV56/59/66, HPV16 and/or HPV18, other 12 HR-HPV types (grouped). (Group B) III. To evaluate human factors affecting usability, acceptability, and preferences for self-collection. (Group B)
OUTLINE: Patients are assigned to 1 of 2 groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
Samples will be shipped to BD-specified testing laboratories for blinded HPV testing as per BD-specified frequency and stability information.
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
- •GROUP A: Willingness and ability to provide a documented informed consent
- •GROUP A: Is 25 years or older
- •GROUP A: Has an intact cervix
- •GROUP A: Has had a referral for colposcopy or cervical excisional procedure in which routine cervical cancer screening has included positive HPV testing (HPV primary screening, co-testing, or atypical squamous cells of undetermined significance [ASC-US] cytology triage) or abnormal cytology performed within the past 12 months preceding the referral visit
- •GROUP A: Willing and able to undergo colposcopy, and if clinically indicated for SOC purposes, a biopsy, endocervical curettage, and/or a cervical excisional procedure, as applicable
- •GROUP B: Willingness and ability to provide a documented informed consent
- •GROUP B: Is 25 years or older
- •GROUP B: Has an intact cervix
- •GROUP B: Eligible for regular cervical cancer screening by current national guidelines
排除标准
- •GROUP A: Is pregnant when presenting for the referral visit or gave birth within the past 3 months
- •GROUP A: Has a known history of excisional or ablative therapy to the cervix (e.g., loop electrosurgical excision procedure [LEEP], cone biopsy, cervical laser surgery, cryotherapy, thermal ablation) in the last 12 months prior to the referral visit
- •GROUP A: Has had a complete or partial hysterectomy, either supracervical or involving removal of the cervix, via self-report or confirmation via medical records
- •GROUP A: Known medical conditions that, in the opinion of the investigator, preclude study participation
- •GROUP A: Previous participation in the SHIP trial (participation is defined as completing the self-collection sampling) or another cervical cancer screening study that involved vaginal sampling within the past 12 months
- •GROUP A: Is experiencing unusual bleeding or pelvic pain
- •GROUP B: Is known to be pregnant when presenting for the screening visit or gave birth within the past 3 months
- •GROUP B: Has a known history of excisional or ablative therapy to the cervix (e.g., LEEP, cone biopsy, cervical laser surgery, cryotherapy, thermal ablation) in the last 12 months prior to the screening visit
- •GROUP B: Has had a complete or partial hysterectomy, either supracervical or involving removal of the cervix, via self-report or confirmation via medical records
- •GROUP B: Known medical conditions that, in the opinion of the investigator, preclude study participation
- •GROUP B: Previous participation in the SHIP Trial (participation is defined as completing the self-collection sampling) or another cervical cancer screening study that involved vaginal sampling within the past 12 months
- •GROUP B: Is experiencing any bleeding (including menstruation) or pelvic pain
- •GROUP B: Is experiencing any active vaginal infection or has used any vaginal products in 48 hours previous to study sample collection
研究组 & 干预措施
Group B (self-collected and clinician-collected samples)
Patients undergo self-collection of two vaginal samples and then undergo clinician-collection of 1 or 2 cervical test samples. Patients may undergo standard of care colposcopy with biopsy/endocervical curettage and/or cervical excisional procedures as clinically indicated.
干预措施: Biospecimen Collection (Procedure)
Group A (self-collected and clinician-collected samples)
Patients undergo self-collection of two vaginal samples and then undergo clinician-collection of a cervical test sample. Patients then undergo standard of care colposcopy with biopsy/endocervical curettage and/or cervical excisional procedures as clinically indicated.
干预措施: Survey Administration (Other)
Group A (self-collected and clinician-collected samples)
Patients undergo self-collection of two vaginal samples and then undergo clinician-collection of a cervical test sample. Patients then undergo standard of care colposcopy with biopsy/endocervical curettage and/or cervical excisional procedures as clinically indicated.
干预措施: Cervical Biopsy (Procedure)
Group B (self-collected and clinician-collected samples)
Patients undergo self-collection of two vaginal samples and then undergo clinician-collection of 1 or 2 cervical test samples. Patients may undergo standard of care colposcopy with biopsy/endocervical curettage and/or cervical excisional procedures as clinically indicated.
干预措施: HPV Self-Collection (Procedure)
Group B (self-collected and clinician-collected samples)
Patients undergo self-collection of two vaginal samples and then undergo clinician-collection of 1 or 2 cervical test samples. Patients may undergo standard of care colposcopy with biopsy/endocervical curettage and/or cervical excisional procedures as clinically indicated.
干预措施: Endocervical Curettage (Procedure)
Group A (self-collected and clinician-collected samples)
Patients undergo self-collection of two vaginal samples and then undergo clinician-collection of a cervical test sample. Patients then undergo standard of care colposcopy with biopsy/endocervical curettage and/or cervical excisional procedures as clinically indicated.
干预措施: Human Papillomavirus Test (Procedure)
Group B (self-collected and clinician-collected samples)
Patients undergo self-collection of two vaginal samples and then undergo clinician-collection of 1 or 2 cervical test samples. Patients may undergo standard of care colposcopy with biopsy/endocervical curettage and/or cervical excisional procedures as clinically indicated.
干预措施: Human Papillomavirus Test (Procedure)
Group B (self-collected and clinician-collected samples)
Patients undergo self-collection of two vaginal samples and then undergo clinician-collection of 1 or 2 cervical test samples. Patients may undergo standard of care colposcopy with biopsy/endocervical curettage and/or cervical excisional procedures as clinically indicated.
干预措施: Survey Administration (Other)
Group A (self-collected and clinician-collected samples)
Patients undergo self-collection of two vaginal samples and then undergo clinician-collection of a cervical test sample. Patients then undergo standard of care colposcopy with biopsy/endocervical curettage and/or cervical excisional procedures as clinically indicated.
干预措施: Biospecimen Collection (Procedure)
Group A (self-collected and clinician-collected samples)
Patients undergo self-collection of two vaginal samples and then undergo clinician-collection of a cervical test sample. Patients then undergo standard of care colposcopy with biopsy/endocervical curettage and/or cervical excisional procedures as clinically indicated.
干预措施: Colposcopy (Procedure)
Group A (self-collected and clinician-collected samples)
Patients undergo self-collection of two vaginal samples and then undergo clinician-collection of a cervical test sample. Patients then undergo standard of care colposcopy with biopsy/endocervical curettage and/or cervical excisional procedures as clinically indicated.
干预措施: Electronic Health Record Review (Other)
Group A (self-collected and clinician-collected samples)
Patients undergo self-collection of two vaginal samples and then undergo clinician-collection of a cervical test sample. Patients then undergo standard of care colposcopy with biopsy/endocervical curettage and/or cervical excisional procedures as clinically indicated.
干预措施: Endocervical Curettage (Procedure)
Group A (self-collected and clinician-collected samples)
Patients undergo self-collection of two vaginal samples and then undergo clinician-collection of a cervical test sample. Patients then undergo standard of care colposcopy with biopsy/endocervical curettage and/or cervical excisional procedures as clinically indicated.
干预措施: Excision (Procedure)
Group A (self-collected and clinician-collected samples)
Patients undergo self-collection of two vaginal samples and then undergo clinician-collection of a cervical test sample. Patients then undergo standard of care colposcopy with biopsy/endocervical curettage and/or cervical excisional procedures as clinically indicated.
干预措施: HPV Self-Collection (Procedure)
Group A (self-collected and clinician-collected samples)
Patients undergo self-collection of two vaginal samples and then undergo clinician-collection of a cervical test sample. Patients then undergo standard of care colposcopy with biopsy/endocervical curettage and/or cervical excisional procedures as clinically indicated.
干预措施: Questionnaire Administration (Other)
Group B (self-collected and clinician-collected samples)
Patients undergo self-collection of two vaginal samples and then undergo clinician-collection of 1 or 2 cervical test samples. Patients may undergo standard of care colposcopy with biopsy/endocervical curettage and/or cervical excisional procedures as clinically indicated.
干预措施: Cervical Biopsy (Procedure)
Group B (self-collected and clinician-collected samples)
Patients undergo self-collection of two vaginal samples and then undergo clinician-collection of 1 or 2 cervical test samples. Patients may undergo standard of care colposcopy with biopsy/endocervical curettage and/or cervical excisional procedures as clinically indicated.
干预措施: Colposcopy (Procedure)
Group B (self-collected and clinician-collected samples)
Patients undergo self-collection of two vaginal samples and then undergo clinician-collection of 1 or 2 cervical test samples. Patients may undergo standard of care colposcopy with biopsy/endocervical curettage and/or cervical excisional procedures as clinically indicated.
干预措施: Electronic Health Record Review (Other)
Group B (self-collected and clinician-collected samples)
Patients undergo self-collection of two vaginal samples and then undergo clinician-collection of 1 or 2 cervical test samples. Patients may undergo standard of care colposcopy with biopsy/endocervical curettage and/or cervical excisional procedures as clinically indicated.
干预措施: Excision (Procedure)
Group B (self-collected and clinician-collected samples)
Patients undergo self-collection of two vaginal samples and then undergo clinician-collection of 1 or 2 cervical test samples. Patients may undergo standard of care colposcopy with biopsy/endocervical curettage and/or cervical excisional procedures as clinically indicated.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Difference in FNR ratio between SC and CC samples (Group A)
时间窗: One-time, up to 30 days
Will report point estimate and 95% CIs.
Clinical sensitivity for self-collected (SC) samples (Group A)
时间窗: One-time, up to 30 days
Will be defined as the probability of testing human papillomavirus (HPV) positive on SC sample given disease positive (e.g., cervical intraepithelial neoplasia \[CIN\]2+). Will report point estimate and 95% confidence intervals (CIs).
Clinical sensitivity for clinician-collected (CC) samples (Group A)
时间窗: One-time, up to 30 days
Will be defined as the probability of testing HPV positive on CC sample given disease positive (e.g., CIN2+). Will report point estimate and 95% CIs.
Sensitivity ratio for SC versus CC samples (Group A)
时间窗: One-time, up to 30 days
Will be defined as the sensitivity of SC divided by the sensitivity of CC. Will report point estimate and 95% CIs.
Difference in clinical sensitivity between SC and CC samples (Group A)
时间窗: One-time, up to 30 days
Will report point estimate and 95% CIs.
Clinical specificity for SC samples (Group A)
时间窗: One-time, up to 30 days
Will be defined as the probability of testing HPV negative on SC sample given disease negative (e.g., \< CIN2). Will report point estimate and 95% CIs.
Clinical specificity for CC samples (Group A)
时间窗: One-time, up to 30 days
Will be defined as the probability of testing HPV negative on CC sample given disease negative (e.g., \< CIN2). Will report point estimate and 95% CIs.
Specificity ratio for SC versus CC samples (Group A)
时间窗: One-time, up to 30 days
Will be defined as the specificity of SC divided by the specificity of CC. Will report point estimate and 95% CIs.
Difference in clinical specificity between SC and CC samples (Group A)
时间窗: One-time, up to 30 days
Will report point estimate and 95% CIs.
False positive rate (FPR) for SC samples (Group A)
时间窗: One-time, up to 30 days
Will be defined as the probability of testing HPV positive on SC sample given \< CIN2. Will report point estimate and 95% CIs.
FPR for CC samples (Group A)
时间窗: One-time, up to 30 days
Will be defined as the probability of testing HPV positive on CC sample given \< CIN2. Will report point estimate and 95% CIs.
FPR ratio for SC versus CC samples (Group A)
时间窗: One-time, up to 30 days
The FPR ratio is the FPR of SC divided by the FP of CC. Will report point estimate and 95% CIs.
Difference in FPR ratio between SC and CC samples (Group A)
时间窗: One-time, up to 30 days
Will report point estimate and 95% CIs.
False negative rate (FNR) for SC samples (Group A)
时间窗: One-time, up to 30 days
Will be defined as the probability of testing HPV negative on SC given CIN2+. Will report point estimate and 95% CIs.
FNR for CC samples (Group A)
时间窗: One-time, up to 30 days
Will be defined as the probability of testing HPV negative on CC given CIN2+. Will report point estimate and 95% CIs.
FNR ratio for SC versus CC samples (Group A)
时间窗: One-time, up to 30 days
The FNR ratio is the FNR of SC divided by the FNR of CC. Will report point estimate and 95% CIs.
Positive percent agreement (Group A)
时间窗: One-time, up to 30 days
Will be defined as the probability of positive on SC given positive on CC, expressed as a percent. Will report point estimate and 95% CIs.
Negative percent agreement (Group A)
时间窗: One-time, up to 30 days
Will be defined as the probability of negative on SC given negative on CC, expressed as a percent. Will report point estimate and 95% CIs.
Positive percent agreement (Group A and Group B)
时间窗: One-time, up to 30 days
Will report point estimate and 95% CIs.
Negative percent agreement (Group A and Group B)
时间窗: One-time, up to 30 days
Will report point estimate and 95% CIs.
Cohen's Kappa (Group A and Group B)
时间窗: One-time, up to 30 days
Will be described as a measure of agreement beyond chance between SC and CC samples, and values will be interpreted as follows: 0.00-0.19 as poor, 0.20-0.39 as fair, 0.40-0.59 as moderate, 0.60-0.79 as good, and 0.80-1.00 as excellent agreement beyond chance. Will report point estimate and 95% CIs.
Test positivity rates (Group A and Group B)
时间窗: One-time, up to 30 days
Will report point estimate and 95% CIs.
Rate of invalid test results (Group A and Group B)
时间窗: One-time, up to 30 days
Will report point estimate and 95% CIs.
次要结局
未报告次要终点