Evaluation of Strategies for Optimal Clinical Management of Women With Atypical Squamous Cells of Undetermined Significance (ASC-US)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,661
- 试验地点
- 1
- 主要终点
- Cumulative Number of Participants Diagnosed by the Community Pathologist With Cervical Intraepithelial Neoplasia Grade 2 or Higher (CIN2+): "Community-based CIN2+"
研究概览
简要总结
Cervical cancer as well cervical preneoplastic abnormalities (CIN2+) are cause by human papillomavirus (HPV) infection. These abnormalities have been historically detected by cervical cytology, but recent evidence shows that HPV testing is superior to cytology to detect cervical lesions that eventually will progress to cancer. Despite evidence, conventional cytology (Pap) remains as a primary screening test in Colombia and HPV test is recommended as a triage test for women with atypical squamous cells of undetermined significance (ASC-US) in settings around the world. Women with ASC-US have low risk to CIN2+ but higher than healthy population, and therefore it is important to provide appropriate clinical management. However, there is no consensus of how to deal women with ASC-US and therefore there are still three strategies for this purpose: 1) immediate colposcopy, 2) repeat conventional cytology at 6 and 12 months and 3) HPV testing. The main objective of this study is to compare the effectiveness and the efficient among the strategies as well as to evaluate the acceptability of the HPV testing in a real-life setting.
详细描述
The aim of this study is to compare the effectiveness and efficiency of immediate colposcopy (IC), repeat conventional cytology at 6 and 12 months (RC) and HPV triage (HPV) (QIAGEN-The digene HPV Test®) for the clinical management of women with ASC-US insured in healthcare management organizations (HMO) within the Colombian health security system. This study randomized 2,661 20-69 years old women with ASC-US, insured in HMOs in Medellin-Colombia to 3 arms: IC, RC and HPV. All women are scheduled for a visit at 2 years after recruitment that includes HPV-test/cytology and colposcopy either if HPV+ (RLU>=1) or abnormal cytology (>=ASC-US). This colposcopy is performed by a trained colposcopist and women are followed-up according to a well-defined algorithm. The fewer high-grade cervical neoplasia (CIN2+) rate at the end of following will determine the most effective arm. The most efficiency arm will be which reach the major effective with the minimum resource (cytologies, colposcopies and histologies) consumed. The resource consumed is being retrieved from the HMOs. This study also pretends to evaluate the acceptability of the HPV testing. This study will allow us to know if within the Colombian health security system, the HPV test will remain superior to repeating cytology and/or to immediate colposcopy as it has been demonstrated in randomized controlled trials carried out in outside settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 69 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ASC-US cytology, living in metropolitan area of Medellin
排除标准
- •Previous abnormal cytology
研究组 & 干预措施
HPV test
Women with ASC-US cytology are HPV tested and those HPV positive are refer to Colposcopy
干预措施: HPV test (Device)
HPV test
Women with ASC-US cytology are HPV tested and those HPV positive are refer to Colposcopy
干预措施: COLPOSCOPY (Procedure)
COLPOSCOPY
Women with ASC-US cytology are immediately refer to colposcopy
干预措施: COLPOSCOPY (Procedure)
CYTOLOGY
Women with ASC-US Cytology are follow-up with cytology at 6 and/or 12 months and be referred to colposcopy if any of these cytologies is ASC-US or higher
干预措施: COLPOSCOPY (Procedure)
CYTOLOGY
Women with ASC-US Cytology are follow-up with cytology at 6 and/or 12 months and be referred to colposcopy if any of these cytologies is ASC-US or higher
干预措施: cytology (Device)
结局指标
主要结局
Cumulative Number of Participants Diagnosed by the Community Pathologist With Cervical Intraepithelial Neoplasia Grade 2 or Higher (CIN2+): "Community-based CIN2+"
时间窗: Two years since the enrolment to the exit visit (inclusive)
Cumulative Cervical Intraepithelial Neoplasia Grade 2 or higher (CIN2+) diagnosed by the community pathologists during the two years of follow-up. The first community-based CIN2+ diagnosis was adjudicated to the participant (including the exit visit if none community-based CIN2+ during the two years of follow-up). This outcome is used for the effectiveness analysis of the three strategies.
次要结局
- Number of Participants Diagnosed by a Panel of External Experts With Cervical Intraepithelial Neoplasia Grade 2 or Higher (CIN2+) at the Exit Visit, Two Years After the Enrolment: "Exit-reviewed CIN2+"(Exit visit (two years after the enrolment))
- Self-esteem(Two years between the enrolment and the exit visit)
- Cumulative Number of Participants Diagnosed by a Panel of External Experts With Cervical Intraepithelial Neoplasia Grade 2 or Higher (CIN2+): "Reviewed CIN2+"(Two years since the enrolment to the exit visit (inclusive))
- Trait Anxiety(Two years between the enrolment and the exit visit)
- Concerns About Fertility, Cancer, and Gynecological Health(Two years between the enrolment and the exit visit)
- Number of Clinical Records (Cytologies, Colposcopies, and Histologies): "Health Care Utilization"(Two years since the enrolment to before the exit visit (i.e., excluding clinical records collected at the exit visit))
- State Anxiety(Two years between the enrolment and the exit visit)
研究者
Gloria I. Sanchez, MSc, PhD
Associate Professor
Universidad de Antioquia