Clinical trial NCT06047236: Immune Biomarker Study for Salivary Gland Carcinoma
Official title: Immune Biomarker Study for Salivary Gland Carcinoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Salivary Gland Tumor
Benign Salivary Gland Tumor
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients presenting for treatment at the participating study centers and meeting the inclusion criteria.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Observation of changes in an established immune matrix (intratumoral and systemic)
timeFrame: Change of the immune matrix from baseline to the end of study period, up to 5 years
measure: Longitudinal immunophenotyping of the patients: Detection of about 30 distinct immune cell (sub)types together with their activation markers during study period
timeFrame: Change of the immunophenotyping from baseline to the end of study period, up to 5 years
measure: Analysis of cytokines in peripheral blood and their change at certain points in the course of treatment
timeFrame: Change of the cytokine expression from baseline to the end of study period, up to 5 years
measure: Analysis of patient's metabolic state
timeFrame: The analyses are conducted from baseline to the end of study period, up to 5 years
measure: Analysis of patient's microbiomic state by examination of saliva, tumor and stool
timeFrame: The analyses are conducted from baseline to the end of study period, up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen, HNO
state: Bavaria
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen, Strahlenklinik
state: Bavaria
Study officials:
affiliation: Universitätsklinikum Erlangen, HNO
name: Sarina Mueller, PD
role: STUDY_DIRECTOR
affiliation: Universitätsklinikum Erlangen, Radiation Oncology
name: Marlen Haderlein, PD
role: STUDY_DIRECTOR
affiliation: Universitätsklinikum Erlangen, Radiation Oncology, Translational Radiobiology
name: Benjamin Frey, PD
role: PRINCIPAL_INVESTIGATOR
References: