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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Page 1 of 1 (2 locations)

1

Universitätsklinikum Erlangen, HNO

Erlangen, Bavaria, Germany, 91054

2

Universitätsklinikum Erlangen, Strahlenklinik

Erlangen, Bavaria, Germany, 91054