Cytology vs. at Home HPV Screening for Detection of CIN 2,3,CIS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,335
- 试验地点
- 4
- 主要终点
- Sensitivity and specificity for CIN 1+ of currently recommended in-clinic cytology screening
研究概览
简要总结
This randomized clinical trial studies home-based HPV or clinic-based Pap screening for cervical cancer. It is not yet known whether home-based screening is more effective, cost-effective, and/or acceptable than clinic-based screening for cervical cancer.
详细描述
PRIMARY OBJECTIVES:
I. Compare the sensitivity and specificity for cervical intraepithelial neoplasia (CIN) of two screening approaches:
- Novel approach: every 3 years high risk-human papillomavirus (HR-HPV) testing of (at home) self-collected samples with in-clinic cytology of HR-HPV positive women and referral to colposcopy of women with cytology > atypical squamous cells of uncertain significance (ASCUS); repeat HPV testing of HR-HPV positive but cytology negative women at one year;
- Currently recommended approach: for women < 30: every 3 years in-clinic cytology screening, with HPV based triage of women with ASCUS and referral to colposcopy of all women with squamous intraepithelial lesion (SIL) and/or HPV+ ASCUS; for women 30+, screening by Papanicolaou (Pap) and HPV, every 2-3 year (depending on previous history) with referral to colposcopy of those who are HPV 16/18+ or with cytology > ASCUS; retesting of those who are positive for other HR-HPV at one year.
II. Compare these two approaches with respect to overall cost-effectiveness and acceptability.
III. Determine the performance and cost-effectiveness of each approach in vaccinated and unvaccinated women < 30.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Able to provide informed consent in English
排除标准
- •Have had hysterectomy
- •Currently pregnant
- •Received treatment of cervical dysplasia with LEEP, cone biopsy, laser procedure or cryotherapy within THREE years
- •Received colposcopy of cervix within TWO years
- •Received Pap test within ONE year
- •Immunocompromised (positive human immunodeficiency virus [HIV] test, transplant recipient, received chemotherapy for cancer, or taking immunosuppressant drugs)
- •Decisionally impaired adults requiring a legally authorized representative
结局指标
主要结局
Sensitivity and specificity for CIN 1+ of currently recommended in-clinic cytology screening
时间窗: Up to 4 years
An intention-to-treat analysis, based upon the initial randomization, will be performed to evaluate differences between study arms (screening strategies). Estimates of sensitivity and specificity for detection of CIN 1+ will be calculated for the two screening strategies using standard methodologies.
Sensitivity and specificity of the standard approach in vaccinated women less than 30 years old
时间窗: Up to 4 years
Estimates of sensitivity and specificity for detection of CIN 1 will be calculated for the two screening strategies and the rate of disease in the 10% sample of test negative subjects in each arm will be extrapolated to the entire study group of test negative subjects in that arm when sensitivity and specificity estimates are calculated. Threshold analyses will also be conducted to identify the range for the cost of the home-based test due to inherent uncertainty
Overall cost-effectiveness and acceptability
时间窗: Up to 4 years
The results from the trial (sensitivity, specificity, and costs) will be used in conjunction with a Markov model to determine cost per LY and cost per QALY. Model outcomes (per 100,000 screened) will include the expected numbers of false-positive test results, colposcopies, cases of CIN 1+, cases of cancer, cancer deaths, life expectancy and quality adjusted life-expectancy. Strategies will be compared using incremental cost-effectiveness ratios. Costs and outcomes will be discounted at 3% annually. One, 2-way and probabilistic sensitivity analyses conducted for all inputs to the models.
Sensitivity and specificity for CIN 1+ of novel home-based testing
时间窗: Up to 4 years
An intention-to-treat analysis, based upon the initial randomization, will be performed to evaluate differences between study arms (screening strategies). Estimates of sensitivity and specificity for detection of CIN 1+ will be calculated for the two screening strategies using standard methodologies.
Sensitivity and specificity of the novel approach in vaccinated women less than 30 years old
时间窗: Up to 4 years
Estimates of sensitivity and specificity for detection of CIN 1+ will be calculated for the two screening strategies and the rate of disease in the 10% sample of test negative subjects in each arm will be extrapolated to the entire study group of test negative subjects in that arm when sensitivity and specificity estimates are calculated. Threshold analyses will also be conducted to identify the range for the cost of the home-based test due to inherent uncertainty
Cost-effectiveness in the novel approach in vaccinated and unvaccinated women less than 30 years old
时间窗: Up to 4 years
Cost-effectiveness in the standard approach in vaccinated and unvaccinated women less than 30 years old
时间窗: Up to 4 years
次要结局
未报告次要终点