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临床试验/NCT03241680
NCT03241680Unknown不适用

Study of Anal Cytologies in Patients With High Grade Cervical Intraepithelial Neoplasia (CIN II and III)

Universidade do Vale do Sapucai2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2017年8月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
80
试验地点
2
主要终点
Study of Anal Cytologies in Patients With High Grade Cervical Intraepithelial Neoplasia (CIN II and III)

研究概览

简要总结

Cervical cancer is the third most frequent neoplasm in Brazilian women (estimated risk of 15.33 cases / 100,000 women by 2014), behind breast and colorectal cancer.

This high incidence is explained by the pre-neoplastic lesions of the cervix being probably related to the practice of unsafe sex and to a poor local immune response against HPV.

Human papillomavirus (HPV) infection affects people of any age, although it is more common in young people, probably due to increased sexual activity in that period.

The association between high-risk HPV and anus neoplasm in men and women with immunodeficiency or immunosuppression has been confirmed and measures related to surveillance are standardized.

In patients without immunodeficiencies, this association is still unclear, which may contribute to the lack of adequate standards to diagnose HPV and prevent cancer of the anus.

The frequency of the cancer of anus previously considered low, is currently in considerable elevation, mainly squamous cell carcinoma (SCC).

The causal relationship between this virus and cancer of the cervix and the anus is established. These facts have motivated the inclusion of this disease as STD, which justifies the necessity of adopting surveillance measures in the clinics of sexual, gynecological and urological diseases.

Cancer of the anus, when diagnosed in the early stage, makes healing possible with less aggressive treatments, but in the advanced stage, abdominoperineal amputation is necessary.

Concerned about possible anal cancer, some gynecologists have referred patients with genital HPV to search for anal infection.

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Female patients aged 18-65 years with an anatomic pathology compatible with CIN II / CIN III, without restriction regarding skin color, race, ethnicity, religion; Patients of the Oncology Gynecology Service of the HCSL, registered in the hospital management system, in outpatient consultations; Those who agree to participate in the study and sign the ICF. Patients attended at the general gynecological surgery outpatient clinic (control group) with no evidence of colpocitological alteration.

排除标准

  • Patients who withdraw the consent term. History of previous anal cancer / anal intraepithelial neoplasia. Immunosuppressed: HIV, SLE, users of immunosuppressive and transplanted drugs.

研究组 & 干预措施

Control Group with conventional citology

No Intervention

Patients who do not have high grade cervical intraepithelial neoplasia and will have anal cytology performed by conventional method

Control Group with liquid based citology

No Intervention

Patients who do not have cervical intraepithelial neoplasia of high grade and will have anal cytology performed by liquid based method

CIN 2-3/Conventional Citology

No Intervention

Patients with high grade cervical intraepithelial neoplasia and will have anal citology performed by conventional method

CIN 2-3/Liquid Based

Active Comparator

Patients with high grade cervical intraepithelial neoplasia and will have anal citology performed by liquid based method

干预措施: Search of anal citology alterations (Diagnostic Test)

结局指标

主要结局

Study of Anal Cytologies in Patients With High Grade Cervical Intraepithelial Neoplasia (CIN II and III)

时间窗: Six months

Search for alterations in the anal cytology of patients with CIN 2-3 in conventional and liquid based anal citology

次要结局

未报告次要终点

研究者

发起方
Universidade do Vale do Sapucai
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lyliana Coutinho Resende Barbosa

MD Phd

Universidade do Vale do Sapucai

研究点 (2)

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