Immune Biomarker Study for Salivary Gland Carcinoma (ImmoGlandula)

University of Erlangen-Nürnberg Medical School

Status: Enrolling

Conditions: Salivary Gland Tumor; Benign Salivary Gland Tumor

Treatments: Other: Sampling

Study type: Observational

Funder types: Other

Identifiers

NCT06047236

ImmoGlandula

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

300 participants in 3 patient groups

Observational Arm

Description:

Initial diagnosis of primary salivary gland carcinoma in the head and neck region

Treatment:

Other: Sampling

Control Group 1

Description:

Initial diagnosis of a benign salivary gland tumor in the head and neck region

Treatment:

Other: Sampling

Control Group 2

Description:

Healthy control group. Functional diseases of the nose or ear (patients with the indication for functional ear surgery and rhinoplasty) without salivary gland tumor.

Treatment:

Other: Sampling