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.

Recruiting

Conditions: head and neck cancer
Head and neck squamous cell carcinoma
10027655

Registration Number: NL-OMON52923

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 80

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

• 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.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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