CIRCOS
The Use of Circulating Biomarkers in Oropharyngeal Cancer and Unknown Primary of Head and Neck - a Prospective Multicenter Study for Treatment Evaluation and Surveillance
Sponsor study identifier
observational
130
1 country
1
Study Start
December 1, 2020
Actual (reported)Primary Completion
March 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
March 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The goal of this observational longitudinal study is to learn about circulating tumor Human Papilloma Virus-DNA (ctHPV-DNA) as a biomarker for HPV positive oropharyngeal cancer and cancer of unknown primary of the head and neck. The main questions it aims to answer are:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 1, 2020
Actual (reported)April 17, 2023
Actual (reported)June 15, 2023
Actual (reported)March 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
March 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The accuracy of ctHPV-DNA as a biomarker for recurrent disease, measured in PPV and NPV
ctHPV-DNA will be evaluated by ddPCR. Two consecutive positive values will be defined as a molecular recurrance. The accuracy of the test will be presented with negative predictive value (NPV) and positive predictive value (PPV) at one, two (interim analysis) and at five year follow-up
5 year follow-up
The correlation between molecular tumor burden (copies/mL) and radiological tumor burden (diameter and volume) using Kendall rank correlation coefficient.
3 months follow-up
A comparison between molecular (copies/mL) and radiological response to treatment according to RECIST (Response Evaluation Criteria in Solid Tumors) using Kruskal wallis test.
Study participants are recruited from multidisciplinary conferences of head and neck cancer at Örebro University hospital - Region Örebro County, Västmanland's hospital - Region Västmanland and Karolinska University hospital - Region Stockholm. Örebro University hospital is a tertiary referral hospital of three regions in central Sweden (Region Värmland, Region Sörmland and Region Dalarna) and therefore patients from these regions will also be included in this study. All patients with OPSCC at any of the study centers will be asked to participate in CIRCOS. All study participants will sign an informed written consent upon inclusion
Anna Oldaeus Almerén
Örebro, Sweden
Almeren AO, Waenerlund M, Landstrom F, von Beckerath M, Qvick A, Carlsson J, Helenius G. Circulating Tumour DNA as a Complementary Tool for Treatment Evaluation in HPV-Associated Head and Neck Squamous Cell Carcinoma: An Observational Cohort Study. Clin Otolaryngol. 2025 Sep;50(5):831-839. doi: 10.1111/coa.14317. Epub 2025 Apr 22.
Qvick A, Andersson E, Oldaeus Almeren A, Waenerlund M, Stenmark B, Karlsson C, Karlsson MG, Helenius G. Sensitive and Specific Droplet Digital PCR Assays for Circulating Tumor HPV DNA: Development, Validation, and Clinical Application in HPV-Associated Cancers. Mol Diagn Ther. 2024 Nov;28(6):835-845. doi: 10.1007/s40291-024-00743-9. Epub 2024 Sep 26.
Plasma samples
Gisela Helenius
Örebro University, Sweden
130 participants (actual enrollment reported by the registry).
First Submitted
April 17, 2023
First Posted
June 15, 2023
Study Start
December 1, 2020
Actual (reported)SURVEILLE-HPV: Evaluation of HPV16 Circulating DNA as Biomarker to Detect the Recurrence, in Order to Improve Post Therapeutic Surveillance of HPV16-driven Oropharyngeal Cancers
3 months follow-up
Contact the study team to confirm eligibility.
Primary Completion
March 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
March 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
June 15, 2023
Record last verified: 2023-04
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Source: ClinicalTrials.gov.
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