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NCT07600515
Evaluation of Persistent Infection by Oncogenic Human Papillomavirus (HPV) in Patients Treated for Cervical Carcinoma and Its Relation to Prognostic Factors
Conditions: Locally Advanced Cervical Cancer, Prognostic Biomarker
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 100
Sponsor: Instituto do Cancer do Estado de São Paulo
Summary
Cervical cancer is strongly associated with HPV infection, yet current post-treatment follow-up relies on cytology and imaging, which have limited accuracy, particularly after radiotherapy. Emerging evidence suggests that HPV clearance is linked to better outcomes and that HPV testing may outperform cytology in detecting recurrence.
This study aims to evaluate a panel of prognostic biomarkers to identify patients at higher risk of recurrence. These include cervical and circulating HPV-DNA (presence, genotype, and load), vaginal microbiota, host DNA methylation, SOD2 expression, and immune profile.
By enabling earlier and more accurate detection of recurrence, these biomarkers may improve patient outcomes, reduce reliance on costly imaging, and support earlier discharge for low-risk patients.
Eligibility Criteria
Inclusion Criteria:
* Diagnosis of HPV-associated squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma
* Treatment-naïve
* FIGO 2018 stage IB3 to IVA
* Candidates for curative-intent pelvic radiotherapy with concurrent chemoradiation
Exclusion Criteria:
* Tumors with rare histology, such as small cell tumors, sarcomas, and lymphomas
* FIGO 2018 stages IA, IB1, IB2, and IVB
* Planned initial treatment is surgical or palliative
* Uncertain primary tumor site (cervix vs. endometrium)
* Pregnant or in the postpartum period
* Immunosuppression (e.g., HIV infection with active disease, autoimmune diseases, transplant recipients)
Source: ClinicalTrials.gov (NCT07600515). StuddyBuddy aggregates publicly available trial information.
