Liquid Biopsy of Head and Neck Cancer Patients in Blood and Saliva (KOHACIN)

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

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Squamous Cell Carcinoma

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.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Markus Wirth, MD; Phone Number: 9416 +49 89 4140; Email: markus.wirth@tum.de
• Study Contact Backup: Name: Christof Winter, MD, PhD; Phone Number: 4765 +49 89 4140; Email: christof.winter@tum.de

Study Locations

• Germany
  • Munich, Germany, 81675
    • Recruiting
    • Klinikum rechts der Isar der Technischen Universitat Munchen
    • Contact: Markus Wirth, MD; Phone Number: 9416 +49 89 4140; Email: markus.wirth@tum.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients treated for HNSCC at Klinikum rechts der Isar der Technischen Universität München

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Neoplasms other than HNSCC

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence-free survival	Recurrence-free survival	Assessed up to 24 months
Overall survival	Overall survival	Assessed up to 24 months

Collaborators and Investigators

• Sponsor: Technical University of Munich
• Investigators: Principal Investigator: Irina Kerle, MD, Technical University of Munich; Principal Investigator: Markus Wirth, MD, Technical University of Munich; Principal Investigator: Christof Winter, MD, PhD, Technical University of Munich

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2017
• Primary Completion (Anticipated): April 1, 2023
• Study Completion (Anticipated): April 1, 2023

Study Registration Dates

• First Submitted: October 25, 2021
• First Submitted That Met QC Criteria: November 4, 2021
• First Posted (Actual): November 16, 2021

Study Record Updates

• Last Update Posted (Actual): April 12, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Liquid Biopsy
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Carcinoma, Squamous Cell; Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck
• Other Study ID Numbers: KOHACIN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No