Study of Anal Cytologies in Patients With High Grade Cervical Intraepithelial Neoplasia (CIN II and III)
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|ClinicalTrials.gov Identifier: NCT03241680|
Recruitment Status : Recruiting
First Posted : August 7, 2017
Last Update Posted : August 7, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Anal Carcinoma Anal Condyloma||Diagnostic Test: Search of anal citology alterations||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study of Anal Cytologies in Patients With High Grade Cervical Intraepithelial Neoplasia (CIN II and III)|
|Actual Study Start Date :||August 2, 2017|
|Estimated Primary Completion Date :||April 30, 2018|
|Estimated Study Completion Date :||May 31, 2018|
No Intervention: 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 Intervention: 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 Intervention: CIN 2-3/Conventional Citology
Patients with high grade cervical intraepithelial neoplasia and will have anal citology performed by conventional method
Active Comparator: CIN 2-3/Liquid Based
Patients with high grade cervical intraepithelial neoplasia and will have anal citology performed by liquid based method
Diagnostic Test: 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).
- Study of Anal Cytologies in Patients With High Grade Cervical Intraepithelial Neoplasia (CIN II and III) [ Time Frame: Six months ]Search for alterations in the anal cytology of patients with CIN 2-3 in conventional and liquid based anal citology
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03241680
|Contact: LYLIANA C R BARBOSAfirstname.lastname@example.org|
|Lyliana C R Barbosa||Recruiting|
|Pouso Alegre, MG, Brazil, 37550000|
|Contact: LYLIANA C R BARBOSA 35988532927 email@example.com|
|Contact: MARCIO E FRANCO RIBEIRO firstname.lastname@example.org|
|Study Chair:||Daniela F Veiga||Vale do Sapucai University|