RecruitingNCT06047236

Immune Biomarker Study for Salivary Gland Carcinoma


Sponsor

University of Erlangen-Nürnberg Medical School

Enrollment

300 participants

Start Date

Jan 8, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

Salivary gland carcinomas (SGC) are rare tumors. The term SGC is not more than an umbrella for a variety of histogenetically, morphologically, and biologically distinct entities. Accordingly, SGCs have not been sufficiently investigated to date. Their rarity makes it challenging to recruit a high number of patients for individual entities in clinical studies, leading to the pooling of patients with different histological subtypes to achieve sufficient participants. The different histological subtypes of SGC exhibit significant differences in their clinicopathological features, including grading, occurrence, and outcome. SGCs usually are stratified into low-, intermediate-, or high-grade tumors. In most kinds of SGC, specific targetable molecular markers are lacking. The inclusion of immunotherapy (IT), however, might improve the outcome of patients suffering from high-grade SGCs. To integrate IT as a therapeutic option for SGC and to facilitate informed therapeutic decisions based on tumor (immune) biology, predictive and prognostic immunological biomarkers are indispensable. In this prospective study, 500 patients will be enrolled, distributed across three arms. The observational cohort includes patients with malignant salivary gland tumors, whereas patients with benign tumors of a salivary gland are grouped in the control group 1. In the control cohort, two patients do not have a salivary gland tumor but have a planned functional surgery of the nose or ear or a maxillofacial surgery. The local immune status of the tumor tissue and the microbiome will be sampled before treatment. In addition, the systemic immune status from peripheral blood will be analyzed before and after surgery and after the adjuvant and definitive chemoradiotherapy (CRT), if applicable. Clinical baseline characteristics and outcome parameters will additionally be collected. Data mining and modeling approaches will be applied to identify interactions between local and systemic immune parameters and to define predictive and prognostic immune signatures based on the evaluated immune markers.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study collects tumor tissue and blood samples from patients with salivary gland cancer to study immune markers — proteins and cells that reflect how the immune system is interacting with the tumor. Better understanding of these markers may help develop future immunotherapy treatments for this rare cancer. **You may be eligible if...** - You have been newly diagnosed with a primary salivary gland cancer (not squamous cell carcinoma) - OR you have a benign salivary gland tumor (for the control group) - OR you are undergoing functional nose or ear surgery (for the second control group) - Your tumor is large enough that a tissue sample can be taken without affecting your standard diagnosis **You may NOT be eligible if...** - You have a squamous cell carcinoma of the salivary gland - Your tumor is too small for safe sample collection - You are not undergoing surgery at the participating institution Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERSampling

Evaluation of immune characteristics by using patient's stool, saliva, blood, and tumour (not in control group 2) samples.


Locations(2)

Universitätsklinikum Erlangen, HNO

Erlangen, Bavaria, Germany

Universitätsklinikum Erlangen, Strahlenklinik

Erlangen, Bavaria, Germany

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NCT06047236


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