Evidence map›Paper›PMID 39325260›Full record

Observational studyMolecular diagnosis & therapy2024

Sensitive and Specific Droplet Digital PCR Assays for Circulating Tumor HPV DNA: Development, Validation, and Clinical Application in HPV-Associated Cancers.

Alvida Qvick, Elin Andersson, Anna Oldaeus Almerén, Max Waenerlund, Bianca Stenmark, Christina Karlsson, Mats G Karlsson, Gisela Helenius

Registry-linked trialAbstract readMulticenter StudyObservational StudyValidation Study
In one paragraph

Observational study in Molecular diagnosis & therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05904327 (The Use of Circulating Biomarkers in Oropharyngeal Cancer and Unknown Primary of Head and Neck - a Prospective Multicenter Study for Treatment Evaluation and Surveillance), which is not on this map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05904327 active not recruitingnot on this map

The Use of Circulating Biomarkers in Oropharyngeal Cancer and Unknown Primary of Head and Neck - a Prospective Multicenter Study for Treatment Evaluation and Surveillance

TypeobservationalSponsorRegion Örebro CountyRan2020 to 2028Enrolled130ConditionsOropharynx Squamous Cell Carcinoma, Oropharynx Cancer, Tonsillar Cancer, Base of the Tongue Carcinoma
3 · Its place in the literature

Who cites it

12 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
  4. Review
  5. Review
  6. Article
  7. Can Oncogenic Animal Viruses Pose a Threat to Humans?Pathogens (Basel, Switzerland) · 2025
    Review
  8. Article
  9. Circulating Tumour DNA as a Complementary Tool for Treatment Evaluation in HPV-Associated Head and Neck Squamous Cell Carcinoma: An Observational Cohort Study.Clinical otolaryngology : official journal of ENT-UK ; official journal of Netherlands Society for Oto-Rhino-Laryngology & Cervico-Facial Surgery · 2025
    Observational
  10. Review
  11. Review
  12. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Alvida QvickDepartment of Laboratory Medicine, Faculty of Medicine and Health, Örebro University, Örebro, Sweden. alvida.qvick@regionorebrolan.com.ORCID 0000-0001-6688-947X
Elin AnderssonClinical Research Center, Örebro University Hospital, Örebro, Sweden.
Anna Oldaeus AlmerénDepartment of Otolaryngology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
Max WaenerlundDepartment of Otolaryngology, Sahlgrenska University Hospital, Göteborg, Sweden.
Bianca StenmarkDepartment of Laboratory Medicine, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
Christina KarlssonSchool of Health Sciences, Örebro University, Örebro, Sweden.
Mats G KarlssonDepartment of Laboratory Medicine, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
Gisela HeleniusATMP Center, Skåne University Hospital, Lund, Sweden.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHuman papillomavirus (HPV) has emerged as a significant contributor to cancer incidence globally, particularly in the context of oropharyngeal squamous cell carcinoma (OPSCC) and cancer of unknown primary (HNCUP). This study aimed to develop and validate droplet digital PCR (ddPCR) assays for the detection of circulating tumor HPV DNA (ctHPV-DNA) in plasma, focusing on high-risk HPV genotypes associated with these cancers.

methodsddPCR assays for HPV16, 18, 33, 35, 56, and 59 were developed and tested using gBlocks, HPV cell-free DNA, fragmented tumor HPV+ DNA, and plasma samples from patients with HPV+ OPSCC (n = 110) and HNCUP (n = 9).

resultsAssays demonstrated robust technical sensitivity across all tested HPV genotypes. Clinical application of the assays on a cohort of patients with HPV+ OPSCC and HNCUP revealed high sensitivity (91.6%) and wide variability in ctHPV-DNA levels. Analyses revealed correlations between ctHPV-DNA levels and TNM stage and tumor viral load. The association between ctHPV-DNA and tumor viral load persisted even after adjusting for TNM stage. At posttreatment, 72.5% of samples had reached undetectable ctHPV-DNA levels. Having detectable ctHPV-DNA posttreatment was associated with a higher ctHPV-DNA level at diagnosis and higher viral load at diagnosis.

conclusionThe findings underscore the potential of ctHPV-DNA as a biomarker for monitoring HPV+ cancers and offer insights into tumor dynamics. Implementation of these assays in clinical practice could enhance no-invasive treatment monitoring and recurrence detection in HPV-associated cancers. CLINICAL TRIALS: NCT05904327.

Indexed as

Circulating Tumor DNADNA, ViralPapillomavirus InfectionsPolymerase Chain ReactionAdultAgedFemaleGenotypeHumansMaleMiddle AgedNeoplasms, Unknown PrimaryOropharyngeal NeoplasmsPapillomaviridaeSensitivity and SpecificityCirculating Tumor DNADNA, Viral

Identifiers

PMID39325260
PMCPMC11512825

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.