Immune Biomarker Study for Salivary Gland Carcinoma

NCT ID: NCT06047236

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-01-08
• Study Completion Date: 2029-09-30

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.

Conditions

Salivary Gland Tumor; Benign Salivary Gland Tumor

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Observational Arm

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

Sampling

Intervention Type: OTHER

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

Sampling

Intervention Type: OTHER

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.

Sampling

Intervention Type: OTHER

Evaluation of immune characteristics by using patient's stool, saliva and blood samples.

Interventions

Sampling

Evaluation of immune characteristics by using patient's stool, saliva and blood samples.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sarina Mueller, PD

Role: STUDY_DIRECTOR

Universitätsklinikum Erlangen, HNO

Marlen Haderlein, PD

Role: STUDY_DIRECTOR

Universitätsklinikum Erlangen, Radiation Oncology

Benjamin Frey, PD

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Erlangen, Radiation Oncology, Translational Radiobiology

Locations

Universitätsklinikum Erlangen, HNO

Erlangen, Bavaria, Germany

Site Status: RECRUITING

Universitätsklinikum Erlangen, Strahlenklinik

Erlangen, Bavaria, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Studiensekretariat

Role: CONTACT

studiensekretariat.ST@uk-erlangen.de

+49913185 ext. 43921

Translation Radiobiology

Role: CONTACT

Anna-Jasmina.Donaubauer@uk-erlangen.de

+49913185 ext. 44925

Facility Contacts

Sarina Mueller, PD

Role: primary

sarina.mueller@uk-erlangen.de

+49-9131-85 ext. 43921

Marlen Haderlein, PD

Role: primary

marlen.haderlein@uk-erlangen.de

+49913185 ext. 33968

Other Identifiers

ImmoGlandula

Identifier Type: -

Identifier Source: org_study_id