Anal Cancer
Conditions
Interventions
This study aims to determine whether anal samples collected by a physician and through self-collection using the Meneguetti brush and stored in liquid medium are adequate (satisfactory) for anal cytol
2. To assess the effectiveness of the Meneguetti brush for self-collection compared to collection by a proctologist in obtaining adequate anal samples
3.To evaluate the tolerability of the Meneguetti brush compared to the conventional cytology brush, as well as the tolerability of the Meneguetti brush when used for self-collection and by the proctol
Sponsors
Instituto Nacional de Infectologia Evandro Chagas - Fiocruz
Laboratorio de pesquisa clínica em infecções sexualmente transmissíveis e síndrome da imunodeficiência humana
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Participants aged 18 years or older will be included, with no history of anal cancer, pelvic radiotherapy, and/or anal canal stenosis, who report engaging in receptive anal sex and who are under care for the human immunodeficiency virus (HIV) or for HIV prevention at the Evandro Chagas National Institute of Infectious Diseases (INI/Fiocruz).
Exclusion criteria
Exclusion criteria: Participants who report the following conditions will be excluded: History of hereditary or acquired coagulopathies; Platelet count below 50,000/µL; Surgical treatments in the anal canal within the previous 6 months; Use of topical medications in the anal canal (such as trichloroacetic acid or imiquimod) within the previous 3 months; High-resolution anoscopy, sigmoidoscopy, or colonoscopy within the previous 3 months; Anal sample collection, whether for anal cytology or other tests, within the previous 3 months; Use of anticoagulants in the last 5 days; Receptive anal sex, use of lubricants, topical products, creams, ointments, or suppositories, and/or anal washing or enema in the 24 hours prior to the visit; Anal complaints (anal pain, bleeding and/or discharge, or tenesmus) and/or findings during anal inspection (mass, ulceration, fissure, fistulous openings, discharge, prolapse, thrombosed hemorrhoids) on the day of screening. Participants presenting with hemorrhoids, warts, or anal skin tags (plicoma) that, in the proctologist's assessment, could interfere with sample collection or safety evaluation will also be excluded. These individuals will be referred to the institution's proctology outpatient clinic for clinical management and will be advised of the possibility of undergoing a new screening after the resolution of these conditions.Participants from Phase 1 are not eligible for participation in Phase 2 of the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effectiveness of the Meneguetti Brush compared to the Conventional Cytology Brush in obtaining adequate anal samples for liquid-based cytology by the proctologist.** ;To evaluate the effectiveness of the Meneguetti Brush in obtaining adequate anal samples through self-collection compared to collection by the proctologist. ;To evaluate the tolerability of the Meneguetti Brush compared to the Conventional Cytology Brush, as well as the tolerability of the Meneguetti Brush when used for self-collection and by the proctologist. | — |
Countries
BR
Contacts
Public ContactMaria Meneguetti Seravali Ramos
Instituto Nacional de Infectologia Evandro Chagas - Fiocruz
Outcome results
None listed