The oropharyngeal microbiome and metabolome as potential novel biomarker for disease progression or treatment response in head and neck squamous cell carcinoma (HNSCC); a pilot study.

The oropharyngeal microbiome and metabolome as potential novel biomarker for disease progression or treatment response in head and neck squamous cell carcinoma (HNSCC); a pilot study. - Oropharyngeal micro- and metabolome in head and neck cancer.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON52923

Enrollment

Registered

2020-06-16

Start date

2021-06-14

Completion date

Unknown

Last updated

2026-07-13

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

Conditions

head and neck cancer Head and neck squamous cell carcinoma

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: For patients: 1. Age >=18 years 2. T1-4N0-3M0 squamous cell carcinoma of the head and neck. 3. With an indication for curative (C)RT or definitive surgery. 4. WHO 0-2 5. Written informed consent, For healthy volunteers: 1. Age >=18 years

Exclusion criteria

Exclusion criteria: • Incurable HNSCC; • Current antibiotic use (topical antibiotics e.g. ear drops, cream are acceptable) ; • The presence of any medical condition that might, in the investigators* opinion, render study participation undesirable or that might obscure interpretation of results.

Design outcomes

Primary

Measure	Time frame
Microbiome assays: To assess the oral-, oropharyngeal and fecal microbiome, which includes bacteria, Archea, viruses, parasites and fungi. RNA and DNA will be isolated from oral swabs and feces for sequencing and molecular methodologies (e.g. PCR, qPCR). Metabolome assays: Saliva bio-specimen will be analysed using Liquid Chromatography Tandem Mass Spectrometry (LC-MSMS).	—

Secondary

Measure	Time frame
The oral/oropharyngeal and gut microbiome and metabolome will be correlated to clinical parameters such as therapy response and survival. In addition, an intra-patient comparison will be made between the actual tumor microbiome/metabolome and adjacent normal mucosa.	—

Countries

Netherlands

Outcome results