Immune Biomarker Study for Salivary Gland Carcinoma

Recruiting

• Conditions: Benign Salivary Gland Tumor; Salivary Gland Tumor
• Interventions: Other: Sampling

• Registration Number: NCT06047236
• Lead Sponsor: University of Erlangen-Nürnberg Medical School

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-09
• Study First Submitted: 2023-09-14
• Study First Submitted QC: 2023-09-14
• Study First Posted: 2023-09-21
• Study Start: 2024-01-08
• Last Update Submitted: 2024-02-27
• Last Update Posted: 2024-02-28
• Primary Completion: 2028-09-30
• Study Completion: 2029-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control Group 2	Sampling	Healthy control group. Functional diseases of the nose or ear (patients with the indication for functional ear surgery and rhinoplasty) without salivary gland tumor.
Observational Arm	Sampling	Initial diagnosis of primary salivary gland carcinoma in the head and neck region
Control Group 1	Sampling	Initial diagnosis of a benign salivary gland tumor in the head and neck region

Primary Outcome Measures

Name	Time	Method
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	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).
Observation of changes in an established immune matrix (intratumoral and systemic)	Change of the immune matrix from baseline to the end of study period, up to 5 years	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).
Analysis of cytokines in peripheral blood and their change at certain points in the course of treatment	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 according to the LIPS technique (Zhou et al. JITC 2021).
Analysis of patient's metabolic state	The analyses are conducted from baseline to the end of study period, up to 5 years	Mass-spectrometric untargeted metabolomic of patients serum/plasma to assess the change of metabolites (pg/ml whole blood) from baseline to end of radiotherapy.
Analysis of patient's microbiomic state by examination of saliva, tumor and stool	The analyses are conducted from baseline to the end of study period, up to 5 years	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)).

Trial Locations

Locations (2)

Universitätsklinikum Erlangen, Strahlenklinik; 🇩🇪 Erlangen, Bavaria, Germany

Universitätsklinikum Erlangen, HNO; 🇩🇪 Erlangen, Bavaria, Germany