Cervix Uteri
Conditions
Interventions
Non-inferiority, single-arm, unblinded and non-randomized study, where 150 patients from participating institutions from June 2016 to April 2019 with suspected alteration of cervical lesions evaluated
Sponsors
Hospital Universitário da Universidade de São Paulo
Ziel Biosciences Pesquisa, Desenvolvimento e Diagnóstico LTDA
Eligibility
Sex/Gender
Female
Age
25 Years to 65 Years
Inclusion criteria
Inclusion criteria: Women between 25 and 65 years old referred for colposcopy due to Pap smear with suspicious changes of neoplastic cervical lesions and/or positive HPV (Human Pappiloma Virus) PCR (Polymerase Chain Reaction). All must agree to participate and sign the Free and Informed Consent Form in advance.
Exclusion criteria
Exclusion criteria: Pregnant women; immunocompromised women; women who have not yet started sexual activity; or those who have already undergone chemotherapy or radiotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome: It is expected to find the non-inferiority of self-collection using the SelfCervix device in relation to collection with a health professional for HPV tests based on studies in the literature carried out in countries that used HPV tests with other self-collectors for cervical cancer screening, such as the United States and Europe.;Outcome found 1: The outcome of the study demonstrated that self-collection with the SelfCervix device was not inferior to professional collection (p=0.01) in the evaluation of HPV DNA and liquid-based cytology, demonstrating 87% accuracy (for both tests), sensitivity of 86% (HPV) and 64% (cytology) and specificity of 90% (HPV) and 100% (cytology). A p<0.05 value was considered significant, with a 95% confidence interval. | — |
Secondary
| Measure | Time frame |
|---|---|
| Não são esperados desfechos secundários. | — |
Countries
Brazil
Contacts
Public ContactCaroline de Farias
Ziel Biosciences Pesquisa, Desenvolvimento e Diagnóstico LTDA
Outcome results
None listed