Moderate cervical dysplasia
Conditions
Interventions
This is an investigator-initiated exploratory, single-arm, open-label (non-masked) clinical study. A total of 29 participants were enrolled and allocated to the intervention group. Additionally, clini
Sponsors
Universidade de São Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Histological diagnosis of high-grade intraepithelial neoplasia induced by HPV infection, with no prior treatment; age = 18 years; signed Informed Consent Form (ICF)
Exclusion criteria
Exclusion criteria: Patients with concomitant cancer; pregnant or breastfeeding patients; patients with significant clinical conditions or undergoing treatments that may interfere with the conduct of the study or the safety and efficacy evaluation of the immunotherapy; immunocompromised patients or those with autoimmune disease; patients unable to provide written informed consent; patients who have been enrolled in other experimental therapeutic protocols
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the histological regression of moderate and severe cervical dysplasia or the absence of residual disease at 6 months post-treatment, as assessed by histopathological analysis of cervical biopsy specimens, with the endpoint measured as the proportion of patients achieving regression to mild cervical dysplasia or no evidence of disease. | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor immunological parameters in patients undergoing therapeutic vaccination, using ELISpot assay and cytokine quantification, with variations in immunological parameters (frequency of cytokine-producing cells, absolute values, and changes from baseline) assessed at 4 weeks after the end of treatment | — |
Countries
BR
Contacts
Public ContactBruna Ribeiro
ImunoTera Soluções Terapêuticas LTDA
Outcome results
None listed