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临床试验/NCT03061435
NCT03061435招募中不适用

Screening for Anal Cancer in Women With High-grade Vulvar Dysplasia or Vulvar Cancer.

Dr. Danielle Vicus1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2021年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
110
试验地点
1
主要终点
Prevalence of abnormal anal cytology and hrHPV DNA in women with VIN 2/3 or vulvar cancer

研究概览

简要总结

Almost half of all women will develop an HPV infection in their lifetime. While most infections are naturally asymptomatic or cleared by the immune system, some persist and can lead to the development of cervical, vulvar, or anal lesions and eventually cancer. Screening regimens for these lesions are currently only in place for the cervix through regular Pap tests. These Pap tests usually involve an examination of the vulva -however, no screening procedures exist for anal cancer for women. Several studies have suggested that women with existing gynecological lesions are more likely to develop anal lesions and anal cancer. Here the investigators propose a multi-center study which seeks to screen for and treat anal cancer in women over the age of 40 with vulvar lesions and a stable immune system. The investigators will achieve this through performing anal Pap smears on eligible women and conducting High Resolution Anoscopy (HRA) and appropriate treatment procedures on those with abnormal anal cells. With enough evidence, there may be an indication to establish regular anal cancer screening measures in this potentially underserved population.

Hypothesis: The investigators hypothesize that at least 40% of women with vulvar cancer or VIN2/3 will have abnormal anal cytology. 35% of the population will be hrHPV DNA positive and 11% will additionally have AIN2/3. This prospective study may lay the groundwork for routine anal screening regimens in Ontario and help shift health policy to treat this population.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Women age ≥ 40
  • •Previous diagnosis of VIN 2/3 or vulvar

排除标准

  • •Women with a previous diagnosis of cancer aside from basal cell carcinoma of the skin, cervical cancer, or vulvar cancer
  • •Women who are HIV positive
  • •Women currently taking immunosuppressant medication
  • •Women who have had a previous hysterectomy

研究组 & 干预措施

Screening anal Pap Smear - Negative (25%)

Other

All patients will receive an anal Pap test. Remaining 25% of patients will proceed to high-resolution anoscopy (HRA) clinic to assess the negative predictive rate of HRA.

干预措施: Screening anal Pap smear - High-resolution anoscopy (Procedure)

Screening anal Pap Smear - Negative (75%)

Other

All patients will receive an anal Pap test. 75% of patients with a negative anal Pap will complete study with no further intervention.

干预措施: Screening anal Pap smear - No high-resolution anoscopy (Procedure)

Screening anal Pap Smear - Positive

Other

All patients will receive an anal Pap test. Any patient with abnormal cytology on their Pap test will be referred to HRA clinic for management. This includes potential biopsy and treatment.

干预措施: Screening anal Pap smear - High-resolution anoscopy (Procedure)

结局指标

主要结局

Prevalence of abnormal anal cytology and hrHPV DNA in women with VIN 2/3 or vulvar cancer

时间窗: 6 months to 1 year

次要结局

  • Assess t he correlation between abnormal anal cytology, hrHPV DNA, and AIN(6 months to 1 year)
  • Prevalence of AIN in women with VIN 2/3 or vulvar cancer(6 months to 1 year)

研究者

发起方
Dr. Danielle Vicus
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr. Danielle Vicus

Dr. Danielle Vicus, MD, MSc, FRCSC

Sunnybrook Health Sciences Centre

研究点 (1)

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