Anal Injury Screening for High Risk HPV in Population With Susceptibility to Anal Cancer Development
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Percentage of positive results for Anal Test system versus anal liquid cytology and anoscopy for the presence of high-risk human papillomaviruses
Study Overview
Brief Summary
The diagnosis of anal cancer is superior with the Anal Test system compared to liquid cytology and anoscopy.
Detailed Description
DESIGN METHODOLOGY: Prospective, cross-sectional, comparative, double-blind, randomized.
STUDY POPULATION:
Group 1, 250 HIV negative patients (150 men and 100 women) from the oncology service who agree to participate in the study and with a negative diagnosis for HIV made at the Infectious Diseases Service.
Group 2, 250 HIV positive patients (150 men and 100 women) attended by the Infectious Disease Service diagnosed with HIV positive. The sample size was adjusted to the donation of 500 Anal Test devices and the subsequent molecular determinations for each sample.
PROCEDURE:
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Men and women between 30 and 65 years old.
- •They agree to participate in the study and sign informed consent.
- •They have not received previous treatments for HPV or had previous intraepithelial lesions or anal cancer.
- •Immunosuppressed patients.
- •Women with LIAG of the genital tract (cervix, vagina, or vulva).
- •Patients who have had anal intercourse
Exclusion Criteria
- •Patients sexually inactive
- •Subjects who had anal sex in less than 24 hours prior to the study.
- •Patients with local medication application (enemas, suppositories).
Arms & Interventions
Group 1, HIV negative patients.
Only HIV negative patients
Intervention: Self test sample (Diagnostic Test)
Group 2, HIV positive patients
Only HIV positive patients
Intervention: Self test sample (Diagnostic Test)
Outcomes
Primary Outcomes
Percentage of positive results for Anal Test system versus anal liquid cytology and anoscopy for the presence of high-risk human papillomaviruses
Time Frame: 12 months
Statistical difference for percentages of the presence of high-risk human papillomaviruses between self-test versus liquid anal cytology.
Secondary Outcomes
- Number and percentage of LSIL and HSIL for patients using self-test (by presence of mRNA for viral proteins E6 and E7) compared to number and percentage of LSIL and HSIL for patients with liquid cytology or with results by biopsy.(12 months)
- Number and percentage of patients to have a positive opinion to use Self-Test system.(12 months)
- Number of predictive value for positive and negative results for self-test versus liquid cytology results(12 months)
- Number and percentage of patients with anal intraepithelial lesions caused by HPV-Ar infection compared between HIV-positive and HIV-negative patients(12 months)
Investigators
Dr. Carlos E. Aranda Flores
Surgeon, specialty in oncology
Hospital General de México Dr. Eduardo Liceaga