NCT06047236

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
66mo left

Started Jan 2024

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress30%
Jan 2024Sep 2031

First Submitted

Initial submission to the registry

September 14, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

January 8, 2024

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2029

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2031

Last Updated

March 16, 2026

Status Verified

December 1, 2025

Enrollment Period

5.7 years

First QC Date

September 14, 2023

Last Update Submit

March 13, 2026

Conditions

Salivary Gland TumorBenign Salivary Gland Tumor

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival (PFS)

    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 Outcomes (7)

  • Locoregional recurrence rate (LRR)

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

  • Occurrence of distant metastases

    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

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

  • Immune status of the resected tumor

    1 year

  • Transcriptional changes in immune cell gene expression

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

  • +2 more secondary outcomes

Study Arms (3)

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

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

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

Interventions

SamplingOTHER

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 regionMalignant salivary gland tumor in the head and neck regionfunctional disorders of the nose or ear

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Universitätsklinikum Erlangen, HNO

Erlangen, Bavaria, 91054, Germany

RECRUITING

Universitätsklinikum Erlangen, Strahlenklinik

Erlangen, Bavaria, 91054, Germany

RECRUITING

Related Publications (7)

  • Donaubauer AJ, Ruhle PF, Becker I, Fietkau R, Gaipl US, Frey B. One-Tube Multicolor Flow Cytometry Assay (OTMA) for Comprehensive Immunophenotyping of Peripheral Blood. Methods Mol Biol. 2019;1904:189-212. doi: 10.1007/978-1-4939-8958-4_8.

    PMID: 30539471RESULT

  • Donaubauer AJ, Becker I, Ruhle PF, Fietkau R, Gaipl US, Frey B. Analysis of the immune status from peripheral whole blood with a single-tube multicolor flow cytometry assay. Methods Enzymol. 2020;632:389-415. doi: 10.1016/bs.mie.2019.03.003. Epub 2019 Apr 4.

    PMID: 32000906RESULT

  • Zhou JG, Donaubauer AJ, Frey B, Becker I, Rutzner S, Eckstein M, Sun R, Ma H, Schubert P, Schweizer C, Fietkau R, Deutsch E, Gaipl U, Hecht M. Prospective development and validation of a liquid immune profile-based signature (LIPS) to predict response of patients with recurrent/metastatic cancer to immune checkpoint inhibitors. J Immunother Cancer. 2021 Feb;9(2):e001845. doi: 10.1136/jitc-2020-001845.

    PMID: 33593828RESULT

  • Hiss S, Eckstein M, Segschneider P, Mantsopoulos K, Iro H, Hartmann A, Agaimy A, Haller F, Mueller SK. Tumour-Infiltrating Lymphocytes (TILs) and PD-L1 Expression Correlate with Lymph Node Metastasis, High-Grade Transformation and Shorter Metastasis-Free Survival in Patients with Acinic Cell Carcinoma (AciCC) of the Salivary Glands. Cancers (Basel). 2021 Feb 25;13(5):965. doi: 10.3390/cancers13050965.

    PMID: 33669038RESULT

  • Freitag V, Lettmaier S, Semrau S, Hecht M, Mantsopoulos K, Muller SK, Traxdorf M, Iro H, Agaimy A, Fietkau R, Haderlein M. High-grade salivary gland cancer: is surgery followed by radiotherapy an adequate treatment to reach tumor control? Results from a tertiary referral centre focussing on incidence and management of distant metastases. Eur Arch Otorhinolaryngol. 2022 May;279(5):2553-2563. doi: 10.1007/s00405-021-07024-9. Epub 2021 Aug 26.

    PMID: 34436631RESULT

  • Haderlein M, Scherl C, Semrau S, Lettmaier S, Uter W, Neukam FW, Iro H, Agaimy A, Fietkau R. High-grade histology as predictor of early distant metastases and decreased disease-free survival in salivary gland cancer irrespective of tumor subtype. Head Neck. 2016 Apr;38 Suppl 1:E2041-8. doi: 10.1002/hed.24375. Epub 2016 Feb 3.

    PMID: 26841273RESULT

  • Donaubauer AJ, Frey B, Agaimy A, Lange F, Mogge L, Fietkau R, Iro H, Munoz LE, Weber M, Kesting M, Gaipl US, Haderlein M, Muller S. Definition of predictive and prognostic immune biomarkers for salivary gland cancer from the intratumoural and systemic immune status: detailed protocol of the prospective, observatory ImmoGlandula study. BMJ Open. 2026 Jan 12;16(1):e100021. doi: 10.1136/bmjopen-2025-100021.

    PMID: 41526019DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood for immune phenotyping and gene sequencing. Blood for producing serum and plasma (both used for soluble factors and metabolic profiling). Saliva for studying the mucosal microbiome. Stool for analyzing the gut microbiome. Tumor swap for examining the tumor's microbiome. Tumor biopsy (not in control group 2) for assessing tumor-infiltrating lymphocytes.

MeSH Terms

Conditions

Salivary Gland Neoplasms

Condition Hierarchy (Ancestors)

Mouth NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsMouth DiseasesStomatognathic DiseasesSalivary Gland Diseases

Study Officials

  • Sarina Mueller, PD

    Universitätsklinikum Erlangen, HNO

    STUDY DIRECTOR

  • Marlen Haderlein, PD

    Universitätsklinikum Erlangen, Radiation Oncology

    STUDY DIRECTOR

  • Benjamin Frey, PD

    Universitätsklinikum Erlangen, Radiation Oncology, Translational Radiobiology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Studiensekretariat

CONTACT

+49913185studiensekretariat.ST@uk-erlangen.de

Translation Radiobiology

CONTACT

+49913185Anna-Jasmina.Donaubauer@uk-erlangen.de

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2023

First Posted

September 21, 2023

Study Start

January 8, 2024

Primary Completion (Estimated)

September 30, 2029

Study Completion (Estimated)

September 30, 2031

Last Updated

March 16, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

DE(2)