Analyzing immune biomarkers in salivary gland tumors
Immune Biomarker Study for Salivary Gland Carcinoma
This study is trying to see if analyzing the immune features of salivary gland tumors can help improve diagnosis and treatment for patients with these tumors.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Erlangen-Nürnberg Medical School Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 2 sites (Erlangen, Bavaria and 1 other locations) |
| Trial ID | NCT06047236 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a primary diagnosis of salivary gland carcinoma or benign salivary gland tumors.
Not a fit: Patients with squamous cell carcinomas or those unable to provide the necessary biological samples may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic and therapeutic strategies for patients with salivary gland tumors.
How similar studies have performed: While similar studies have explored tumor biomarkers, this specific approach combining multiple omics analyses and machine learning is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Erlangen, Bavaria and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.