Cell-free Tumor DNA in Head and Neck Cancer Patients

NCT ID: NCT03942380

Last Updated: 2021-09-21

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-01

Study Completion Date

2025-02-01

Brief Summary

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This study investigates if head and neck squamous cell carcinoma can be tracked with cell-free tumor DNA, RNA or HPV-DNA, in blood samples from patients referred with suspicion of cancer, and if it can be used in detecting recurrence in patients already diagnosed and treated for head and neck squamous cell carcinoma.

Detailed Description

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Conditions

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Head and Neck Cancer Head and Neck Neoplasms Head and Neck Squamous Cell Carcinoma Oropharynx Cancer Oropharynx Neoplasm Oropharynx Carcinoma Oral Cavity Cancer Oral Cancer Oral Neoplasm Larynx Cancer Larynx Carcinoma Larynx Neoplasm Nasopharyngeal Carcinoma Nasopharyngeal Cancer Nasopharynx Neoplasm Hypopharynx Cancer Hypopharynx Neoplasm Hypopharynx Carcinoma Sinonasal Carcinoma Thyroid Carcinoma Thyroid Cancer Thyroid Neoplasms Salivary Gland Cancer Salivary Gland Neoplasms Salivary Gland Carcinoma Sinonasal Cancer Sinonasal Neoplasm

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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Cell-free tumor DNA

The aim is to differentiate between patients with head and neck cancer from those without based on a blood sample.

Group Type OTHER

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 cell free DNA, RNA and HPV-DNA

Identifying recurrence

The aim is to identify recurrence through serial monitoring patients with blood samples.

Group Type OTHER

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 cell free DNA, RNA and HPV-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 cell free DNA, RNA and HPV-DNA

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Patients 18 years old or older
* Suspicion of head and neck cancer

Exclusion Criteria

* Diagnosed with cancer within the last 3 years ( apart from basal cell carcinoma)
* Diagnosed with an inflammatory or haematological disease after the age of 18
* Received chemotherapy or immunosuppressive treatment within the last 3 years
* Underwent a FNA ( fine-needle aspiration biopsy) or a biopsy from the head and neck region within 1 week.
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

Department of Otorhinolaryngology, Head and Neck Surgery and Audiology

UNKNOWN

Sponsor Role collaborator

Christian von Buchwald

OTHER

Sponsor Role lead

Responsible Party

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Christian von Buchwald

Clinical Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Christian Von Buchwald, MD, DMSc

Role: PRINCIPAL_INVESTIGATOR

Department of Otorhinolaryngology, Head and Neck Surgery and Audiology

Locations

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University Hospital of Copenhagen, Rigshospitalet

Copenhagen, Capital Region, Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Christian Grønhøj, MD, Ph.D

Role: CONTACT

004526276374

Other Identifiers

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1301261

Identifier Type: -

Identifier Source: org_study_id

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