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

Head and Neck Squamous Cell Carcinoma Clinical Trial

— KOHACIN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05122507
• Other study ID #: KOHACIN
• Status: Recruiting
• Start date: May 8, 2017
• Est. completion date: April 2023

Study information

• Verified date: April 2023
• Source: Technical University of Munich
• Contact: Markus Wirth, MD
• Phone: +49 89 4140
• Email: markus.wirth[@]tum.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 2023
• Est. primary completion date: April 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Head and neck squamous cell carcinoma (HNSCC)

• Written informed consent

Exclusion Criteria:

• Neoplasms other than HNSCC

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Head and Neck Squamous Cell Carcinoma
• Squamous Cell Carcinoma of Head and Neck

Locations

Country	Name	City	State
Germany	Klinikum rechts der Isar der Technischen Universität München	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Technical University of Munich

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early recurrence detection lead time	Lead time is defined as time between liquid-biopsy based recurrence detection and clinical recurrence or progression.	Assessed up to 24 months
Secondary	Recurrence-free survival	Recurrence-free survival	Assessed up to 24 months
Secondary	Overall survival	Overall survival	Assessed up to 24 months