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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03241680
Enrollment
80
Registered
2017-08-07
Start date
2017-08-02
Completion date
2018-05-31
Last updated
2017-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anal Carcinoma, Anal Condyloma

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.

Interventions

DIAGNOSTIC_TESTSearch 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).

Sponsors

Universidade do Vale do Sapucai
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes

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. \-

Design outcomes

Primary

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

Countries

Brazil

Contacts

Primary ContactLYLIANA C R BARBOSA
magibarbosa@gmail.com35988532927

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026