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

Studien-Informationen Einschlusskriterien Studien-Rationale

Rekrutierend

NCT-Nummer:
NCT05122507

Studienbeginn:
Mai 2017

Letztes Update:
12.04.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Technical University of Munich

Collaborator:
-

Studienleiter

Irina Kerle, MD
Principal Investigator
Technical University of Munich

Markus Wirth, MD
Principal Investigator
Technical University of Munich

Christof Winter, MD, PhD
Principal Investigator
Technical University of Munich

Kontakt

Markus Wirth, MD
Kontakt:
Phone: +49 89 4140
Phone (ext.): 9416
E-Mail: markus.wirth@tum.de» Kontaktdaten anzeigen

Christof Winter, MD, PhD
Kontakt:
Phone: +49 89 4140
Phone (ext.): 4765
E-Mail: christof.winter@tum.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Klinikum rechts der Isar der Technischen Universität München
81675 Munich
(Bayern)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Markus Wirth, MD
Phone: +49 89 4140
Phone (ext.): 9416
E-Mail: markus.wirth@tum.de» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Head and neck squamous cell carcinoma (HNSCC)

- Written informed consent

Exclusion Criteria:

- Neoplasms other than HNSCC

Studien-Rationale

Primary outcome:

1. Early recurrence detection lead time (Time Frame - Assessed up to 24 months):
Lead time is defined as time between liquid-biopsy based recurrence detection and clinical recurrence or progression.

Secondary outcome:

1. Recurrence-free survival (Time Frame - Assessed up to 24 months):
Recurrence-free survival

2. Overall survival (Time Frame - Assessed up to 24 months):
Overall survival

Quelle: ClinicalTrials.gov

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