Evaluation of Persistent Infection by Oncogenic Human Papillomavirus (HPV) in Patients Treated for Cervical Carcinoma and Its Relation to Prognostic Factors (ANIHTA)
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.
Aperçu de l'étude
Statut
Description détaillée
The association between HPV infection and cervical carcinoma is established in medicine. Tests that assess the presence of HPV in the cervix are already used in primary screening and post-treatment follow-up of cervical precursor lesions (CINs), allowing earlier discharge from tertiary centers, reducing costs and the number of outpatients returns.
Post-treatment follow-up of cervical carcinoma is performed with cervical-vaginal cytology and imaging tests. However, there are already studies demonstrating that both the sensitivity and specificity of cytology are low, leading to false-positive diagnoses or late diagnoses of recurrences, since the treatment with radiotherapy, the treatment of choice for locally advanced cervical carcinoma, can lead to cytological alterations not always related to carcinogenesis.
For cervical carcinoma, there are few studies on the role of the persistence of viral infection in the therapeutic response and recurrence of the disease, most of which are retrospective and with few patients. Despite this, the results show that viral clearance is associated with better outcomes. In addition, when studying the comparison between HPV testing and cervical-vaginal cytology in predicting recurrences at 3 years, HPV testing was shown to be superior in both sensitivity and specificity. Since cervical carcinoma is the third most common in Brazilian women and currently follow-up is conducted with low-accuracy tests, it is of paramount importance that new methodologies be studied, aiming at more accurate and earlier diagnoses of recurrences.
In this context, this project aims to evaluate different prognostic biomarkers that could indicate the group of patients at higher risk of recurrence.
The biomarkers analyzed will be presence, genotyping and load of cervical HPV-DNA, presence of circulating HPV-DNA, vaginal microbiota profile, host DNA methylation, SOD2 expression in tumor tissue and the patient's immunological profile.
The results of this study will identify early cases with a higher chance of recurrence for early treatment, aiming to increase the cure of this population. In addition, such biomarkers can replace high-cost imaging tests currently used and encourage early discharge in the group with clearance of HPV infection.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Maria Luiza ND Genta, MD
- Numéro de téléphone: 2670 +55 11 38932000
- E-mail: maria.genta@hc.fm.usp.br
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
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)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
|---|
|
Locally advanced cervical cancer patients
cervical cancer HPV positive
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
recurrence after curative-intent treatment
Délai: 18 months
|
evaluate the relationship between the occurrence of recurrences after curative-intent treatment and the persistence of HPV infection
|
18 months
|
Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 86076225.2.0000.0068
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .