NCT05904327

Brief Summary

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:

  • Can ctHPV-DNA be used for treatment evaluation in HPV positive oropharyngeal cancer and cancer of unknown primary of the head and neck?
  • Can circulating HPV-DNA be used as a biomarker for recurrent disease during surveillance? Participants will be asked to leave plasma samples at diagnose, at the end of treatment and at every clinical follow-up. The patients are there own controls.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
23mo left

Started Dec 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
Dec 2020Mar 2028

Study Start

First participant enrolled

December 1, 2020

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

April 17, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 15, 2023

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2028

Last Updated

June 15, 2023

Status Verified

April 1, 2023

Enrollment Period

7.3 years

First QC Date

April 17, 2023

Last Update Submit

June 13, 2023

Conditions

Oropharynx Squamous Cell CarcinomaOropharynx CancerTonsillar CancerBase of the Tongue Carcinoma

Keywords

circulating tumor DNAHPVhuman papilloma virus

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • 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.

    3 months follow-up

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Oropharyngeal cancer
  • Cancer of unknown primary in the head and neck

You may not qualify if:

  • Previous treatment of cancer in the oropharynx.
  • Previous treatment of unknown primary tumor.
  • Remote metastases
  • Patients unwilling or unable to comply with the study protocol and follow-up schedule

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anna Oldaeus Almerén

Örebro, Sweden

Location

Related Publications (2)

  • 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.

    PMID: 40260766DERIVED

  • 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.

    PMID: 39325260DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Plasma samples

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and NeckOropharyngeal NeoplasmsTonsillar Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by SitePharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Gisela Helenius

    Örebro University, Sweden

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2023

First Posted

June 15, 2023

Study Start

December 1, 2020

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

March 31, 2028

Last Updated

June 15, 2023

Record last verified: 2023-04

Locations

SE(1)