Immune Biomarker Study for Salivary Gland Carcinoma (ImmoGlandula)

Aims of this study are analyses of tumor metabolome, tumor transcriptome and tumor proteome as well as of the immune infiltration, separated by histological entity. These data will subsequently be compared with the with the detailed immune status determined in the patient's peripheral blood and saliva using machine learning techniques, among others, to create a biomarker cluster for salivary gland tumors. These can be used in clinical routine.

In addition, the investigators would like to study a subset of patients from freshly resected tumor organoids from freshly resected tumor tissue according to already established methods in order to mechanistic investigations of prognostic parameters.

Study Overview

• Status: Recruiting
• Conditions: Salivary Gland Tumor; Benign Salivary Gland Tumor
• Intervention / Treatment: Other: Sampling

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Studiensekretariat; Phone Number: 43921 +49913185; Email: studiensekretariat.ST@uk-erlangen.de
• Study Contact Backup: Name: Translation Radiobiology; Phone Number: 44925 +49913185; Email: Anna-Jasmina.Donaubauer@uk-erlangen.de

Study Locations

• Germany
  • Bavaria
    • Erlangen, Bavaria, Germany, 91054
      • Recruiting
      • Universitätsklinikum Erlangen, Strahlenklinik
      • Contact: Marlen Haderlein, PD; Phone Number: 33968 +49913185; Email: marlen.haderlein@uk-erlangen.de
    • Erlangen, Bavaria, Germany, 91054
      • Recruiting
      • Universitätsklinikum Erlangen, HNO
      • Contact: Sarina Mueller, PD; Phone Number: 43921 +49-9131-85; Email: sarina.mueller@uk-erlangen.de

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observational Arm; 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 and blood samples.
Control Group 1; 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 and blood samples.
Control Group 2; 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 and blood samples.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Observation of changes in an established immune matrix (intratumoral and systemic)	Different immune cells and tumor cell markers will characterize immunological groups using cluster analysis. Immune matrix of patients assessed by liquid immune profile-based signature (LIPS) (acc. Zhou et al. Journal for ImmunoTherapy of Cancer (JITC), 2021) and Tumour Associated Lymphocytes (TAL).	Change of the immune matrix 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	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 according to the LIPS technique (Zhou et al. JITC 2021).	Change of the immunophenotyping from baseline to the end of study period, up to 5 years
Analysis of cytokines in peripheral blood and their change at certain points in the course of treatment	Electrochemiluminescent MULTI-ARRAY measurement of concentration (pg/ml whole blood) cytokines/chemoattractant cytokines in the serum/plasma of the patients according to the LIPS technique (Zhou et al. JITC 2021).	Change of the cytokine expression from baseline to the end of study period, up to 5 years
Analysis of patient's metabolic state	Mass-spectrometric untargeted metabolomic of patients serum/plasma to assess the change of metabolites (pg/ml whole blood) from baseline to end of radiotherapy.	The analyses are conducted 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	16S rRNA deep sequencing of microbiome in salvia, tumour and stool samples to assess the presence and relative distribution of microbiotes (Operational taxonomic units (OTUs)).	The analyses are conducted from baseline to the end of study period, up to 5 years

Collaborators and Investigators

• Sponsor: University of Erlangen-Nürnberg Medical School
• Investigators: 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

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2024
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2029

Study Registration Dates

• First Submitted: September 14, 2023
• First Submitted That Met QC Criteria: September 14, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Stomatognathic Diseases; Mouth Diseases; Salivary Gland Diseases; Mouth Neoplasms; Salivary Gland Neoplasms
• Other Study ID 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