Immune Biomarker Study for Salivary Gland Carcinoma (ImmoGlandula)

March 13, 2026 updated by: University of Erlangen-Nürnberg Medical School
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Germany
    • Bavaria
      • Erlangen, Bavaria, Germany, 91054
        • Recruiting
        • Universitätsklinikum Erlangen, Strahlenklinik
        • Contact:
      • Erlangen, Bavaria, Germany, 91054
        • Recruiting
        • Universitätsklinikum Erlangen, HNO
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients presenting for treatment at the participating study centers and meeting the inclusion criteria.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Malignant salivary gland tumor in the head and neck region
Initial diagnosis of primary salivary gland carcinoma in the head and neck region
Other: Sampling
Evaluation of immune characteristics by using patient's stool, saliva, blood, and tumour (not in control group 2) samples.
Benign salivary gland tumor in the head and neck region
Initial diagnosis of a benign salivary gland tumor in the head and neck region
Other: Sampling
Evaluation of immune characteristics by using patient's stool, saliva, blood, and tumour (not in control group 2) samples.
functional disorders of the nose or ear
Healthy control group. Functional diseases of the nose or ear (patients with the indication for functional ear surgery and rhinoplasty) without salivary gland tumor.
Other: Sampling
Evaluation of immune characteristics by using patient's stool, saliva, blood, and tumour (not in control group 2) samples.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
From baseline to the end of study period, up to 5 years
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.
From baseline to the end of study period, up to 5 years
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.
Change of the immunophenotyping from baseline to the end of study period, up to 5 years
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.
1 year
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.
Change of the immunophenotyping from baseline to the end of study period, up to 5 years
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.
The analyses are conducted from baseline to the end of study period, up to 5 years
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.
Change of the cytokine expression from baseline to the end of study period, up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Erlangen-Nürnberg Medical School

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Sarina Mueller, PD, Universitätsklinikum Erlangen, HNO
  • Study Director: Marlen Haderlein, PD, Universitätsklinikum Erlangen, Radiation Oncology
  • Principal Investigator: Benjamin Frey, PD, Universitätsklinikum Erlangen, Radiation Oncology, Translational Radiobiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 8, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 14, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 21, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ImmoGlandula

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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