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Liquid Biopsy of Head and Neck Cancer Patients in Blood and Saliva

Liquid Biopsy of Head and Neck Cancer Patients in Blood and Saliva

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05122507
Acronym
KOHACIN
Enrollment
200
Registered
2021-11-16
Start date
2017-05-08
Completion date
2023-04-30
Last updated
2023-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Squamous Cell Carcinoma

Keywords

Liquid Biopsy

Brief summary

Prospective study for therapy monitoring of locally advanced and metastatic head and neck cancer patients by detection of circulating tumor nucleic acids in peripheral blood and saliva

Detailed description

Clinical examination including imaging and - if necessary - tissue biopsy sampling - is the current clinical standard in therapy monitoring of metastatic head and neck tumors. This includes both the initial diagnosis, the assessment of the therapeutic response during ongoing chemotherapy / radiochemotherapy and follow-up care with the aim of detecting recurrences at an early stage. The detection of circulating nucleic acids as well as proteins in the peripheral blood and saliva could represent a minimally invasive and exact method for the assessment of the tumor burden, for the early detection of recurrences and for the individual assessment of the therapy response in patients with head and neck cancer. The present study aims to evaluate the value of tumor-specific nucleic acids and proteins in peripheral blood and saliva as possible biomarkers for minimally invasive therapy monitoring of head and neck tumors. For this purpose, Next Generation Sequencing (NGS), ELISA and quantitative polymerase chain reaction (PCR) methods are used as diagnostic methods. NGS initially enables the creation of a genetic profile of the primary tumor with targeted massive parallel sequencing of frequently mutated genes in head and neck tumors. The amount of nucleic acids in the peripheral blood and saliva is then quantified by means of digital PCR with the aid of specifically designed digital PCR assays. In addition, tumor-associated nucleic acids and proteins in the primary tumor, blood and saliva are examined. The aim is to examine if the amount of tumor specific circulating nucleic acids and the concentration of protein biomarkers found in the blood and saliva are associated with the response to treatment, early detection of recurrence, and the overall prognosis.

Interventions

None listed

Sponsors

Technical University of Munich
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Head and neck squamous cell carcinoma (HNSCC) * Written informed consent

Exclusion criteria

* Neoplasms other than HNSCC

Design outcomes

Primary

MeasureTime frameDescription
Early recurrence detection lead timeAssessed up to 24 monthsLead time is defined as time between liquid-biopsy based recurrence detection and clinical recurrence or progression.

Secondary

MeasureTime frameDescription
Recurrence-free survivalAssessed up to 24 monthsRecurrence-free survival
Overall survivalAssessed up to 24 monthsOverall survival

Countries

Germany

Contacts

Primary ContactMarkus Wirth, MD
markus.wirth@tum.de+49 89 4140
Backup ContactChristof Winter, MD, PhD
christof.winter@tum.de+49 89 4140

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026