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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorInstituto do Cancer do Estado de São Paulo

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial population

Patients referred to ICESP

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

100 Participants
are grouped into 1 trial group
Group A: Locally advanced cervical cancer patients

Trial outcomes

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

Time frame
18 months

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: