HPV-associated Oropharyngeal Carcinoma (HPV-OPC) (HPV-OPC)
17. juli 2026 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Forhold
Detaljert beskrivelse
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).
Studietype
Intervensjonell
Registrering (Antatt)
35
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Martina Lojová, PhD
- Telefonnummer: +420543136232
- E-post: martina.lojova@mou.cz
Studer Kontakt Backup
- Navn: Martin Bartošík, PhD
- Telefonnummer: +420543133306
- E-post: martin.bartosik@mou.cz
Studiesteder
-
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Czech Republic
-
Brno, Czech Republic, Tsjekkia, 65653
- Rekruttering
- Masaryk Memorial Cancer Institute
-
Ta kontakt med:
- Martina Lojová, PhD
- Telefonnummer: +420543136232
- E-post: martina.lojova@mou.cz
-
Ta kontakt med:
- Martin Martošík, PhD
- Telefonnummer: +420543133306
- E-post: martin.bartosik@mou.cz
-
Hovedetterforsker:
- Tomáš Novotný, MUDr.
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: p16 positive OPC patients
20 patients with OPC who were indicated for standard radiation therapy or concomitant chemoradiation therapy and who were p16-positive.
|
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.
Andre navn:
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.
Andre navn:
|
|
Aktiv komparator: 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).
|
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.
Andre navn:
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.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Correlation of HPV DNA Levels Measured by a New Electrochemical Method Versus Standard Quantitative Polymerase Chain Reaction (qPCR)
Tidsramme: Baseline (pre-treatment), Week 4 of radiotherapy, end of radiotherapy (approx. Week 7), and 3 months post-radiotherapy
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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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change From Baseline in HPV16 Viral Load in Plasma, Oral Swabs, and Oral Rinses
Tidsramme: 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.
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Baseline (pre-treatment), Week 4 of radiotherapy, end of radiotherapy (approx. Week 7), and 3 months post-radiotherapy.
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Tomáš Novotný, MUDr., Masaryk Memorial Cancer Institute
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Rettig EM, Faden DL, Sandhu S, Wong K, Faquin WC, Warinner C, Stephens P, Kumar S, Kuperwasser C, Richmon JD, Uppaluri R, Varvares M, Sethi R, Hanna GJ, Sroussi H. Detection of circulating tumor human papillomavirus DNA before diagnosis of HPV-positive head and neck cancer. Int J Cancer. 2022 Oct 1;151(7):1081-1085. doi: 10.1002/ijc.33996. Epub 2022 Mar 16.
- Das D, Hirayama S, Aye L, Bryan ME, Naegele S, Zhao B, Efthymiou V, Mendel J, Fisch AS, Guan Z, Kroller L, Michels BE, Waterboer T, Richmon JD, Adalsteinsson V, Lawrence MS, Crowson MG, Iafrate AJ, Faden DL. Circulating tumor human papillomavirus DNA whole genome sequencing enables human papillomavirus-associated oropharynx cancer early detection. J Natl Cancer Inst. 2026 Jan 1;118(1):58-67. doi: 10.1093/jnci/djaf249.
- Izadi N, Strmiskova J, Anton M, Hausnerova J, Bartosik M. LAMP-based electrochemical platform for monitoring HPV genome integration at the mRNA level associated with higher risk of cervical cancer progression. J Med Virol. 2024 Oct;96(10):e70008. doi: 10.1002/jmv.70008.
- Izadi N, Sebuyoya R, Moranova L, Hrstka R, Anton M, Bartosik M. Electrochemical bioassay coupled to LAMP reaction for determination of high-risk HPV infection in crude lysates. Anal Chim Acta. 2021 Dec 1;1187:339145. doi: 10.1016/j.aca.2021.339145. Epub 2021 Oct 5.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
25. mai 2026
Primær fullføring (Antatt)
1. mars 2027
Studiet fullført (Antatt)
1. mars 2027
Datoer for studieregistrering
Først innsendt
7. juli 2026
Først innsendt som oppfylte QC-kriteriene
17. juli 2026
Først lagt ut (Faktiske)
22. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
22. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
17. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- A6/26
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
IPD to be shared in pseudonymized form during the study.IPD to be published in anonymized form.
IPD-delingstidsramme
after study completion
Tilgangskriterier for IPD-deling
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.
IPD-deling Støtteinformasjonstype
- CSR
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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