Study of Anal Cytologies in Patients With High Grade Cervical Intraepithelial Neoplasia (CIN II and III)
NCT ID: NCT03241680
Last Updated: 2017-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2017-08-02
2018-05-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Control Group with conventional citology
Patients who do not have high grade cervical intraepithelial neoplasia and will have anal cytology performed by conventional method
No interventions assigned to this group
Control Group with liquid based citology
Patients who do not have cervical intraepithelial neoplasia of high grade and will have anal cytology performed by liquid based method
No interventions assigned to this group
CIN 2-3/Conventional Citology
Patients with high grade cervical intraepithelial neoplasia and will have anal citology performed by conventional method
No interventions assigned to this group
CIN 2-3/Liquid Based
Patients with high grade cervical intraepithelial neoplasia and will have anal citology performed by liquid based method
Search of anal citology alterations
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).
Interventions
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Search of anal citology alterations
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).
Eligibility Criteria
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Inclusion Criteria
\-
Exclusion Criteria
\-
18 Years
65 Years
FEMALE
Yes
Sponsors
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Universidade do Vale do Sapucai
OTHER
Responsible Party
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Lyliana Coutinho Resende Barbosa
MD Phd
Principal Investigators
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Daniela F Veiga
Role: STUDY_CHAIR
Vale do Sapucai University
Locations
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Lyliana C R Barbosa
Pouso Alegre, Minas Gerais, Brazil
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Citologia anal
Identifier Type: -
Identifier Source: org_study_id
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