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HPV-associated Oropharyngeal Carcinoma (HPV-OPC) (HPV-OPC)

17 luglio 2026 aggiornato da: Masaryk Memorial Cancer Institute

Validation of a New Method for Monitoring HPV Infection in Patients With Head and Neck Cancers

This study focuses on the longitudinal monitoring of HPV infection in patients with head and neck cancers, particularly oropharyngeal carcinoma (OPC), using a new electrochemical detection method. This method has already been successfully developed and validated for cervical cancer. The aim of the project is to monitor the dynamics of HPV viral load before the start of treatment and during conservative radiation therapy or concurrent chemoradiation therapy. HPV will be analyzed from oral swabs, oral cavity washings, and plasma as part of a small prospective study. The results of the new method will be correlated with standard techniques, particularly qPCR. Longitudinal monitoring may contribute to the individualization and potential de-escalation of treatment in selected patients.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Patients with HPV-positive head and neck tumors, primarily OPC, who are indicated for conservative radiation therapy or concurrent chemoradiation therapy will be enrolled in the study. At defined time points (before the start of treatment and during treatment), oral swabs, oral cavity washings, and peripheral blood samples will be collected, from which plasma will be isolated for analysis of viral ctDNA. We estimate approximately 20 patients with OPC indicated for radiotherapy alone or concurrent chemoradiotherapy who are p16-positive. Negative controls will be patients with OPC indicated for radiotherapy alone or concurrent chemoradiotherapy who are p16-negative (approximately 10-15).

Tipo di studio

Interventistico

Iscrizione (Stimato)

35

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Cechia
    • Czech Republic
      • Brno, Czech Republic, Cechia, 65653
        • Reclutamento
        • Masaryk Memorial Cancer Institute
        • Contatto:
        • Contatto:
        • Investigatore principale:
          • Tomáš Novotný, MUDr.

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • a patient with an oropharyngeal tumor indicated for curative radiation therapy or chemoradiotherapy
  • if radiation therapy or chemoradiotherapy was preceded by surgery, the patient may be enrolled if the lesion persists on imaging studies
  • the lesion must be a histologically confirmed squamous cell carcinoma with known p16 status
  • age ≥ 18 years
  • the subject must be willing and able to provide written informed consent for specimen collection
  • ability to communicate effectively with the investigator in the local language, and ability to understand and comply with the study requirements

Exclusion Criteria:

  • previous induction chemotherapy
  • unknown p16 status, incomplete or inadequate histology-e.g., adenocarcinoma, melanoma, lymphoma,
  • previous radiation therapy to the oropharynx
  • palliative patients indicated for accelerated radiation therapy with a treatment duration of < 5.5 weeks
  • age < 18 years
  • pregnant or breastfeeding women
  • patients in the terminal stage of life
  • severe alcohol and/or drug abuse during treatment

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Ricerca sui servizi sanitari
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: p16 positive OPC patients
20 patients with OPC who were indicated for standard radiation therapy or concomitant chemoradiation therapy and who were p16-positive.
Test diagnostico: HPV p16
Monitoring changes in HPV DNA levels during therapy can predict the clinical response to treatment and, in the future, may allow for the safe de-escalation of the intensity of radiation therapy or chemoradiation in selected patients. We will also determine the appropriate method for collecting DNA samples so that, in the future, sampling can be as minimally invasive as possible while maintaining the necessary sensitivity and specificity. By comparing the dynamics of local mucosal samples with those of blood samples, we can observe how these dynamics differ in the event of a local or systemic relapse.
Altri nomi:
  • oral swabs
  • oral cavity washings
  • peripheral blood samples
Test diagnostico: HPV testing - positive results
Monitoring changes in HPV DNA levels during therapy can predict the clinical response to treatment and, in the future, may allow for the safe de-escalation of the intensity of radiation therapy or chemoradiation in selected patients. We will also determine the appropriate method for collecting DNA samples so that, in the future, sampling can be as minimally invasive as possible while maintaining the necessary sensitivity and specificity. By comparing the dynamics of local mucosal samples with those of blood samples, we can observe how these dynamics differ in the event of a local or systemic relapse.
Altri nomi:
  • oral swabs
  • oral cavity washings
  • peripheral blood samples
Comparatore attivo: p16 negative OPC patients
The negative controls will be patients with OPC who are indicated for radiotherapy alone or concomitant chemoradiotherapy and who are p16-negative (approximately 10-15).
Test diagnostico: HPV p16
Monitoring changes in HPV DNA levels during therapy can predict the clinical response to treatment and, in the future, may allow for the safe de-escalation of the intensity of radiation therapy or chemoradiation in selected patients. We will also determine the appropriate method for collecting DNA samples so that, in the future, sampling can be as minimally invasive as possible while maintaining the necessary sensitivity and specificity. By comparing the dynamics of local mucosal samples with those of blood samples, we can observe how these dynamics differ in the event of a local or systemic relapse.
Altri nomi:
  • oral swabs
  • oral cavity washings
  • peripheral blood samples
Test diagnostico: HPV testing - negative results
Monitoring changes in HPV DNA levels during therapy can predict the clinical response to treatment and, in the future, may allow for the safe de-escalation of the intensity of radiation therapy or chemoradiation in selected patients. We will also determine the appropriate method for collecting DNA samples so that, in the future, sampling can be as minimally invasive as possible while maintaining the necessary sensitivity and specificity. By comparing the dynamics of local mucosal samples with those of blood samples, we can observe how these dynamics differ in the event of a local or systemic relapse.
Altri nomi:
  • oral swabs
  • oral cavity washings
  • peripheral blood samples

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Correlation of HPV DNA Levels Measured by a New Electrochemical Method Versus Standard Quantitative Polymerase Chain Reaction (qPCR)
Lasso di tempo: Baseline (pre-treatment), Week 4 of radiotherapy, end of radiotherapy (approx. Week 7), and 3 months post-radiotherapy
Assessment of the diagnostic agreement between a novel electrochemical biosensor and the standard qPCR method for detecting HPV infection in patients with HPV-positive oropharyngeal cancer (OPC). Data will be reported as the correlation coefficient and sensitivity/specificity of the electrochemical method relative to the gold standard.
Baseline (pre-treatment), Week 4 of radiotherapy, end of radiotherapy (approx. Week 7), and 3 months post-radiotherapy

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline in HPV16 Viral Load in Plasma, Oral Swabs, and Oral Rinses
Lasso di tempo: Baseline (pre-treatment), Week 4 of radiotherapy, end of radiotherapy (approx. Week 7), and 3 months post-radiotherapy.
Quantification of HPV16 DNA concentration (measured in copies/mL) across three distinct matrices: (a) circulating DNA extracted from plasma, (b) oral swabs, and (c) oral rinses. Measurements will be performed using both standard quantitative PCR (qPCR) and the new electrochemical biosensor to track viral clearance dynamics during and after treatment.
Baseline (pre-treatment), Week 4 of radiotherapy, end of radiotherapy (approx. Week 7), and 3 months post-radiotherapy.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Masaryk Memorial Cancer Institute

Investigatori

  • Investigatore principale: Tomáš Novotný, MUDr., Masaryk Memorial Cancer Institute

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

25 maggio 2026

Completamento primario (Stimato)

1 marzo 2027

Completamento dello studio (Stimato)

1 marzo 2027

Date di iscrizione allo studio

Primo inviato

7 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

17 luglio 2026

Primo Inserito (Effettivo)

22 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

22 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

17 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • A6/26

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

IPD to be shared in pseudonymized form during the study.IPD to be published in anonymized form.

Periodo di condivisione IPD

after study completion

Criteri di accesso alla condivisione IPD

During the study, data will be managed in pseudonymized form in a protected database environment, available only for study team.After completion of the study, the data will be fully anonymized for publication purposes. All publication outputs of the study will be carried out by a team of researchers led by the principal investigator. The submission of each publication is subject to the approval of the principal investigator.The results of this study may be published or presented at scientific meetings after approval by the PI and always after anonymization of the subjects' personal data in accordance with Act No. 101/2000 Coll., on the protection of personal data.

Tipo di informazioni di supporto alla condivisione IPD

  • RSI

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Oropharyngeal Carcinoma (OPC)

Prove cliniche su HPV p16

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Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Ukraine

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

3
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