Analyzing immune biomarkers in salivary gland tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study focuses on analyzing the tumor metabolome, transcriptome, and proteome of salivary gland tumors, alongside assessing immune infiltration based on histological types. The study aims to compare these tumor characteristics with the immune status determined from patients' peripheral blood and saliva using advanced machine learning techniques. The goal is to create a biomarker cluster that can be utilized in clinical practice for better diagnosis and treatment of salivary gland tumors. Additionally, a subset of patients will undergo mechanistic investigations using freshly resected tumor organoids.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Observational group

   * Initial diagnosis of a primary salivary gland carcinoma in the head and neck region (no squamous cell carcinomas)
   * Specimen collection from the center of the tumor when the primary tumor is sufficiently large without that the pathological assessment is impaired
2. Control group 1

   * Initial diagnosis of a benign salivary gland tumor in the head and neck region
   * Specimen collection from the center of the tumor when the primary tumor is sufficiently large without that the pathological assessment is impaired
3. Control group 2

   * functional diseases of the nose or ear (patients with the indication for functional ear surgery and rhinoplasty)
   * Specimen collection with sufficiently large resectate during a functional nose surgery

for all groups:

* Willingness of patients to collect blood, saliva and stool and consent to the preservation of all samples for study purposes.
* Age ≥ 18 years
* sufficient cognitive ability of the patients to understand the purpose of the study and to understand the purpose of the study and agree to it

Exclusion Criteria:

* Distant metastasis at the time of diagnosis and simultaneous second cancers, i.e. at study inclusion
* Malignancy in the last 5 years regardless of location (except basal cell carcinoma or cis of the uterine cervix)
* Carcinomas for which specimen collection is not possible or likely without compromising the compromise the pathological evaluation
* Persistent drug or medication abuse
* Patients who are unable or unwilling to comply with protocol and to be treated
* Patients who are represented by a legal guardian
* Patients who are not suitable for participation in the study due to a language barrier

Where it's running

• Universitätsklinikum Erlangen, HNO
  Erlangen, Bavaria, Germany Recruiting
• Universitätsklinikum Erlangen, Strahlenklinik
  Erlangen, Bavaria, Germany Recruiting

Study contacts

• Principal investigator: Benjamin Frey, PD — Universitätsklinikum Erlangen, Radiation Oncology, Translational Radiobiology
• Study coordinator: Studiensekretariat
• Email: studiensekretariat.ST@uk-erlangen.de
• Phone: +49913185

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.