Clinical trial · Observational
Monitoring and Early Response Evaluation Using HPV DNA - A Study on Patients With HPV-positive Throat Cancer (MER-HPV)
Analysis of HPV DNA in Plasma in Patients With HPV-positive Oropharyngeal Squamous Cell Carcinoma - a Prospective Study of HPV DNA Levels for Treatment Response and Surveillance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this clinical trial is to determine the value of circulating tumour HPV DNA (human papilloma virus DNA found in the blood) at diagnosis, during treatment, and in the follow-up of patients diagnosed and treated for throat cancer caused by HPV. The main question to answer is if the presence of HPV DNA in the blood one month after the treatment is useful in detecting remaining tumour or relapse within two years after treatment. The participants will be asked to provide blood tests: 1. before treatment 2. weekly during the treatment 3. on all scheduled follow-up appointments 4. on all unplanned appointments where a relapse is suspected
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oropharynx Squamous Cell Carcinoma | Oropharynx Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood sample | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients with HPV-positive OPC
- description
- Patients with HPV-positive OPC. They will provide blood samples before during and after treatment to evaluate treatment response and for early detection of recurrence
- interventionNames
- Diagnostic Test: Blood sample
Primary outcomes (1)
- measure
- The sensitivity of detectable ctHPVDNA one month after (c)RT completion
- timeFrame
- From inclusion to two years after treatment
- description
- To determine if detectable ctHPVDNA one month post (C)RT is useful to detect residual or recurrent tumours diagnosed within two years.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Only patients with an HPV-positive primary tumour will eventually be eligible for inclusion. Non-detectable ctHPVDNA at diagnosis will not be a reason for exclusion. 2. Age \>18 years. 3. Able to give informed consent. 4. The patient will be treated with curative intent. Exclusion Criteria: Patients with a short life expectancy, psychiatric or addictive disorders, or other medical conditions which might impair patient compliance may be excluded at the discretion of the investigator.
References
Publications (7)
- BACKGROUNDHammarstedt L, Lindquist D, Dahlstrand H, Romanitan M, Dahlgren LO, Joneberg J, Creson N, Lindholm J, Ye W, Dalianis T, Munck-Wikland E. Human papillomavirus as a risk factor for the increase in incidence of tonsillar cancer. Int J Cancer. 2006 Dec 1;119(11):2620-3. doi: 10.1002/ijc.22177. PMID 16991119
- BACKGROUNDHaring CT, Dermody SM, Yalamanchi P, Kang SY, Old MO, Chad Brenner J, Spector ME, Rocco JW. The future of circulating tumor DNA as a biomarker in HPV related oropharyngeal squamous cell carcinoma. Oral Oncol. 2022 Mar;126:105776. doi: 10.1016/j.oraloncology.2022.105776. Epub 2022 Feb 17. PMID 35183912
- BACKGROUNDChera BS, Kumar S, Shen C, Amdur R, Dagan R, Green R, Goldman E, Weiss J, Grilley-Olson J, Patel S, Zanation A, Hackman T, Blumberg J, Patel S, Thorp B, Weissler M, Yarbrough W, Sheets N, Mendenhall W, Tan XM, Gupta GP. Plasma Circulating Tumor HPV DNA for the Surveillance of Cancer Recurrence in HPV-Associated Oropharyngeal Cancer. J Clin Oncol. 2020 Apr 1;38(10):1050-1058. doi: 10.1200/JCO.19.02444. Epub 2020 Feb 4. PMID 32017652
- BACKGROUNDRutkowski TW, Mazurek AM, Snietura M, Hejduk B, Jedrzejewska M, Bobek-Billewicz B, d'Amico A, Piglowski W, Wygoda A, Skladowski K, Kolosza Z, Widlak P. Circulating HPV16 DNA may complement imaging assessment of early treatment efficacy in patients with HPV-positive oropharyngeal cancer. J Transl Med. 2020 Apr 15;18(1):167. doi: 10.1186/s12967-020-02330-y. PMID 32293457
- BACKGROUNDTanaka H, Takemoto N, Horie M, Takai E, Fukusumi T, Suzuki M, Eguchi H, Komukai S, Tatsumi M, Isohashi F, Ogawa K, Yachida S, Inohara H. Circulating tumor HPV DNA complements PET-CT in guiding management after radiotherapy in HPV-related squamous cell carcinoma of the head and neck. Int J Cancer. 2021 Feb 15;148(4):995-1005. doi: 10.1002/ijc.33287. Epub 2020 Sep 30. PMID 32895945
- BACKGROUNDO'Boyle CJ, Siravegna G, Varmeh S, Queenan N, Michel A, Pang KCS, Stein J, Thierauf JC, Sadow PM, Faquin WC, Wang W, Deschler DG, Emerick KS, Varvares MA, Park JC, Clark JR, Chan AW, Busse PM, Corcoran RB, Wirth LJ, Lin DT, Iafrate AJ, Richmon JD, Faden DL. Cell-free human papillomavirus DNA kinetics after surgery for human papillomavirus-associated oropharyngeal cancer. Cancer. 2022 Jun 1;128(11):2193-2204. doi: 10.1002/cncr.34109. Epub 2022 Feb 9.