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

U

Universidade do Vale do Sapucai

Status

Unknown

Conditions

Anal Carcinoma
Anal Condyloma

Treatments

Diagnostic Test: Search of anal citology alterations

Study type

Interventional

Funder types

Other

Identifiers

NCT03241680
Citologia anal

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

Female

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

80 participants in 4 patient groups

Control Group with conventional citology
No Intervention group
Description:
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 group
Description:
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 group
Description:
Patients with high grade cervical intraepithelial neoplasia and will have anal citology performed by conventional method
CIN 2-3/Liquid Based
Active Comparator group
Description:
Patients with high grade cervical intraepithelial neoplasia and will have anal citology performed by liquid based method
Treatment:
Diagnostic Test: Search of anal citology alterations

Trial contacts and locations

1

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Central trial contact

LYLIANA C R BARBOSA

Data sourced from clinicaltrials.gov

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