Status:
RECRUITING
Immune Biomarker Study for Salivary Gland Carcinoma
Lead Sponsor:
University of Erlangen-Nürnberg Medical School
Conditions:
Salivary Gland Tumor
Benign Salivary Gland Tumor
Eligibility:
All Genders
18+ years
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 com...
Eligibility Criteria
Inclusion
- 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
- 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
- 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
- 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
Key Trial Info
Start Date :
January 8 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2029
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06047236
Start Date
January 8 2024
End Date
September 30 2029
Last Update
February 28 2024
Active Locations (2)
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1
Universitätsklinikum Erlangen, HNO
Erlangen, Bavaria, Germany, 91054
2
Universitätsklinikum Erlangen, Strahlenklinik
Erlangen, Bavaria, Germany, 91054