Can Recurrence of Cancer in the Oropharynx be Detected by Blood Samples?

NCT ID: NCT06592716

Last Updated: 2025-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-02

Study Completion Date

2028-12-31

Brief Summary

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This study investigates if longitudinal analyses of cell-free HPV-DNA in blood samples can be utilized to detect recurrence in patients diagnosed and treated for HPV-positive oropharyngeal squamous cell carcinoma.

Detailed Description

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Conditions

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Oropharynx Cancer Oropharynx Cancer, Metastatic Oropharynx Cancer, Recurrent Oropharyngeal Carcinoma Oropharyngeal Squamous Cell Carcinoma (OPSCC)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Identify recurrence

The aim is to identify recurrence through longitudial analyses of circulating tumor HPV-DNA (ctHPV-DNA ) from blood samples.

Liquid biopsy

Intervention Type DIAGNOSTIC_TEST

The intervention is a liquid biopsy as a blood sample taken in a peripheral vein. The blood samples are analyzed for ctHPV-DNA.

Interventions

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Liquid biopsy

The intervention is a liquid biopsy as a blood sample taken in a peripheral vein. The blood samples are analyzed for ctHPV-DNA.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Patients with newly diagnosed HPV+ (and/or p16+) oropharyngeal squamous cell carcinoma
* Above 18 years of age
* Informed consent

Exclusion Criteria

* The patient does not speak or understand Danish
* patients recieving palliative treatment
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Copenhagen University Hospital, Denmark

OTHER

Sponsor Role collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Christian Grønhøj Larsen

Senior Registrar, PhD, DMSci, Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christian von Buchwald, Professor, MD, DMSci

Role: STUDY_CHAIR

Department of Otorhinolaryngology, Head and Neck Surgery and Audiology, Rigshospitalet

Locations

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Department of Otorhinolaryngology, Head and Neck Surgery and Audiology

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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p-2023-15163

Identifier Type: OTHER

Identifier Source: secondary_id

H-23071576

Identifier Type: -

Identifier Source: org_study_id

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