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NCT Number: NCT06047236

Immune Biomarker Study for Salivary Gland Carcinoma

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.

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Key information

Conditions

Salivary Gland Tumor Benign Salivary Gland Tumor Head and Neck Neoplasms Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Site Salivary Gland Diseases Salivary Gland Neoplasms Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsklinikum Erlangen, HNO, Erlangen, Bavaria, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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
  • 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

Treatment and study plan

Sampling

Other

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

Primary outcomes

  1. Progression-free survival (PFS)

    Time frame: 2 years

    As a primary clinical endpoint, the progression-free survival (PFS) of the patients in the observational cohort will be analyzed after two years.

Secondary outcomes

  1. Locoregional recurrence rate (LRR)

    Time frame: From baseline to the end of study period, up to 5 years

    Secondary clinical endpoints, the locoregional recurrence rate (LRR) after two and five years in the observational cohort will be addressed.

  2. Occurrence of distant metastases

    Time frame: From baseline to the end of study period, up to 5 years

    The occurrence of distant metastases after two and five years in the observational cohort will be addressed.

  3. Longitudinal immunophenotyping of the patients: Detection of about 30 distinct immune cell (sub)types together with their activation markers during study period

    Time frame: Change of the immunophenotyping from baseline to the end of study period, up to 5 years

    The distribution of immune cells and messenger substances in the blood will be examined by means of immunophenotyping in order to add the systemic immune cell composition.

    Flow cytometric assessment of the amount of circulating immune cell-distribution per milliliter whole blood.

  4. Immune status of the resected tumor

    Time frame: 1 year

    The local immune status of the resected tumor is assessed by examining various immunological parameters during the pathological analysis of the tissue, which includes the expression of immune checkpoint molecules on the cells of the tumor microenvironment, such as PD1, its respective ligands or TIM3 and LAG3. Further, the infiltration of numerous of different immune cell populations in the tumor tissue will be examined, which includes CD19+ CD20+ B cells, CD4+ and CD8+ T cells or neutrophilic granulocytes.

  5. Transcriptional changes in immune cell gene expression

    Time frame: Change of the immunophenotyping from baseline to the end of study period, up to 5 years

    Blood is also drawn into RNA stabilization tubes to create cell lysates for long-term storage and to isolate total RNA from blood cells. Cell pellets from whole blood are preserved for the extraction of nucleic acids. The collection and storage of biomaterials are managed by the Central Biobank Erlangen (CeBE). Transcriptional analyses will be conducted using whole-exome sequencing, RNA sequencing, digital droplet PCR, or real-time quantitative PCR.

  6. Analysis of patient's microbiomic state by examination of saliva, tumor and stool

    Time frame: The analyses are conducted from baseline to the end of study period, up to 5 years

    For the microbiome analysis, stool, saliva, and tumor smear samples are collected preoperatively (stool and saliva) and after the tumor excision (tumor smear). The composition of the oral, bowel, and tumor microbiome is determined through metagenomic analyses to identify all non-human species present in the samples. The qualitative and quantitative diversity of the microbiome is then evaluated using bioinformatics approaches.

  7. Analysis of cytokines and metabolites in peripheral blood and their change at certain points in the course of treatment

    Time frame: Change of the cytokine expression from baseline to the end of study period, up to 5 years

    Electrochemiluminescent MULTI-ARRAY measurement of concentration (pg/ml whole blood) cytokines/chemoattractant cytokines in the serum/plasma of the patients. Mass spectrometry will be employed to analyze changes in metabolites from the serum and plasma.

Study contacts

Contact information is provided by the study sponsor or research team.

Studiensekretariat

CONTACT

[email protected]

+49913185 ext. 43921

Translation Radiobiology

CONTACT

[email protected]

+49913185 ext. 44925

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Registry information

Acronym: ImmoGlandula

Important dates

Study start
2024
Primary completion
2029
Study completion
2031
First posted
Sep 21, 2023
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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