See and Treat in an Outpatient Setting in Women Above 45 Years With Cervical Dysplasia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 6
- 主要终点
- Cervical intraepithelial neoplasia ≥ grade 2 (CIN2+) lesion after referral with a positive cervical screening test
研究概览
简要总结
The study will investigate if implementation of "see and treat" in the outpatient clinic can optimize the diagnosis, clinical follow-up and treatment of older women with positive cervical screening test.
详细描述
In Denmark, 370 women are diagnosed with cervical cancer every year and approximately 100 women die from the disease. Young women can be protected with the HPV vaccine, but it will take decades before the vaccine has an effect on older women. Women who are HPV positive have a risk of developing severe dysplasia of 25-55% within 10 years. Compared to younger women, older women are also more likely to be diagnosed with advanced-stage disease and their mortality is high. Due to retraction of the transformation zone into the cervical canal and atrophy of the mucosa the performance of colposcopy is low. Furthermore, the sensitivity of cytology decreases with age. This makes it very difficult to obtain sufficient biopsies and therefore postmenopausal women are often required to undergo colposcopy two to three times. Waiting for a final diagnosis and treatment not only has a large mental and practical impact on the women themselves, but it is also an economic burden for the health care system.
"See and treat" is a procedure that involves cervical cytology and HPV test, a colposcopy, cervical biopsies, and finally a loop electrosurgical excisional procedure by which the transformation zone is removed. This approach allows women to be diagnosed and treated in one visit.
In this project, the aim is to investigate if the implementation of "see and treat" in a gynecological outpatient clinic can optimize the diagnostics, clinical follow-up, and treatment of older women with abnormal cervical cytology or HPV-infection.
Participants Women aged ≥ 45 years with cervical dysplasia and/or a positive HPV test are referred from the general practitioner to the gynecological department.
Procedure At each inclusion site, the local project manager evaluates all the referred women for possible inclusion. Project information is sent either by e-mail or letter to eligible women. At the outpatient clinic, the eligible women will be informed about the project and asked to sign an informed consent form regarding their participation in the project.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women ≥ 45 years with a positive screening test (abnormal cytology and/or persistence HPV positive) who are referred to the Department of Obstetrics and Gynecology.
- •Type 2 or 3 transformation zone (a partly or invisible transformation zone).
排除标准
- •Type 1 transformation zone (fully visible)
- •Current or previous diagnosis of cervical cancer.
- •Pregnancy or pregnancy wish.
- •Previously cone biopsy
结局指标
主要结局
Cervical intraepithelial neoplasia ≥ grade 2 (CIN2+) lesion after referral with a positive cervical screening test
时间窗: The histological diagnose from the Pathological Department will be available 8 weeks after inclusion.
The prevalence of CIN2+ lesions in women ≥45 years included in the study
Concordance between cytology and histology
时间窗: The histological diagnose from the Pathological Department will be available 8 weeks after inclusion.
Concordance between cytology, biopsies and cone biopsy in the ability to detect CIN2+ changes
Clearance of HPV
时间窗: This will be available 7 months after inclusion.
Clearance rate of HPV after 6 months
Complication rate
时间窗: Complication rate will be evaluated 6 months after inclusion.
Complication rate of bleeding, infection and/or stenosis
次要结局
未报告次要终点