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

Study Overview
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Brief Summary
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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.

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

Conditions
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Anal Carcinoma, Anal Condyloma

Intervention / Treatment
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* Diagnostic Test: Search of anal citology alterations


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. - Exclusion Criteria: Patients who withdraw the consent term. History of previous anal cancer / anal intraepithelial neoplasia. Immunosuppressed: HIV, SLE, users of immunosuppressive and transplanted drugs. -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group with conventional citology<br>Patients who do not have high grade cervical intraepithelial neoplasia and will have anal cytology performed by conventional method | |
| No Intervention: Control Group with liquid based citology<br>Patients who do not have cervical intraepithelial neoplasia of high grade and will have anal cytology performed by liquid based method | |
| No Intervention: CIN 2-3/Conventional Citology<br>Patients with high grade cervical intraepithelial neoplasia and will have anal citology performed by conventional method | |
| Active Comparator: CIN 2-3/Liquid Based<br>Patients with high grade cervical intraepithelial neoplasia and will have anal citology performed by liquid based method | Diagnostic Test: Search of anal citology alterations<br>* All patients with a pathological diagnosis of CIN II and III, and in the general gynecological surgery outpatient clinic, will be selected at the outpatient clinic of Oncology Gynecology of the HCSL for a period of six months. Patients who meet the eligibility criteria will be clarified about the study, and only those who agree to participate will be included, by signing the informed consent form (TCLE).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study of Anal Cytologies in Patients With High Grade Cervical Intraepithelial Neoplasia (CIN II and III) | Search for alterations in the anal cytology of patients with CIN 2-3 in conventional and liquid based anal citology | Six months |