Evaluation of Persistent Infection by Oncogenic Human Papillomavirus (HPV) in Patients Treated for Cervical Carcinoma and Its Relation to Prognostic Factors

NCT07600515 | Not Yet Recruiting

• 1 other identifier: 86076225.2.0000.0068
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Locally Advanced Cervical Cancer; Prognostic Biomarker

Keywords

Cervical cancer recurrent or persistent

Outcome Measures

Primary Outcomes (1)

• recurrence after curative-intent treatment

  evaluate the relationship between the occurrence of recurrences after curative-intent treatment and the persistence of HPV infection

  18 months

Study Arms (1)

Locally advanced cervical cancer patients

cervical cancer HPV positive

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients referred to ICESP

You may qualify if:

• 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 -

You may not qualify if:

• 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)

Sponsors & Collaborators

• Instituto do Cancer do Estado de São Paulo: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood cervical sample

Central Study Contacts

Maria Luiza ND Genta, MD

CONTACT

+55 11 38932000; maria.genta@hc.fm.usp.br

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: May 20, 2026
• Study Start: May 10, 2026
• Primary Completion (Estimated): May 10, 2029
• Study Completion (Estimated): May 10, 2030
• Last Updated: May 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share