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

Not Applicable

• Conditions: Anal Carcinoma; Anal Condyloma
• Interventions: Diagnostic Test: Search of anal citology alterations

• Registration Number: NCT03241680
• Lead Sponsor: Universidade do Vale do Sapucai

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-08
• Study Start: 2017-08-02
• Study First Submitted: 2017-08-02
• Study First Submitted QC: 2017-08-02
• Last Update Submitted: 2017-08-02
• Study First Posted: 2017-08-07
• Last Update Posted: 2017-08-07
• Primary Completion: 2018-04-30
• Study Completion: 2018-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CIN 2-3/Liquid Based	Search of anal citology alterations	Patients with high grade cervical intraepithelial neoplasia and will have anal citology performed by liquid based method

Primary Outcome Measures

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

Trial Locations

Locations (1)

Lyliana C R Barbosa; 🇧🇷 Pouso Alegre, MG, Brazil