Immune Biomarker Study for Salivary Gland Carcinoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Erlangen-Nürnberg Medical School
About this trial
Salivary gland carcinomas (SGC) are rare tumors. The term SGC is not more than an umbrella for a variety of histogenetically, morphologically, and biologically distinct entities. Accordingly, SGCs have not been sufficiently investigated to date. Their rarity makes it challenging to recruit a high number of patients for individual entities in clinical studies, leading to the pooling of patients with different histological subtypes to achieve sufficient participants. The different histological subtypes of SGC exhibit significant differences in their clinicopathological features, including grading, occurrence, and outcome. SGCs usually are stratified into low-, intermediate-, or high-grade tumors. In most kinds of SGC, specific targetable molecular markers are lacking. The inclusion of immunotherapy (IT), however, might improve the outcome of patients suffering from high-grade SGCs. To integrate IT as a therapeutic option for SGC and to facilitate informed therapeutic decisions based on tumor (immune) biology, predictive and prognostic immunological biomarkers are indispensable. In this prospective study, 500 patients will be enrolled, distributed across three arms. The observational cohort includes patients with malignant salivary gland tumors, whereas patients with benign tumors of a salivary gland are grouped in the control group 1. In the control cohort, two patients do not have a salivary gland tumor but have a planned functional surgery of the nose or ear or a maxillofacial surgery. The local immune status of the tumor tissue and the microbiome will be sampled before treatment. In addition, the systemic immune status from peripheral blood will be analyzed before and after surgery and after the adjuvant and definitive chemoradiotherapy (CRT), if applicable. Clinical baseline characteristics and outcome parameters will additionally be collected. Data mining and modeling approaches will be applied to identify interactions between local and systemic immune parameters and to define predictive and prognostic immune signatures based on the evaluated immune markers.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Patients presenting for treatment at the participating study centers and meeting the inclusion criteria.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Sampling
Other interventionEvaluation of immune characteristics by using patient's stool, saliva, blood, and tumour (not in control group 2) samples.
Treatment groups
300 Participants
are divided into 3 treatment groupsGroup A: Malignant salivary gland tumor in the head and neck region1 intervention
Group B: Benign salivary gland tumor in the head and neck region1 intervention
Group C: functional disorders of the nose or ear1 intervention
Trial outcomes
Primary outcomes
1
Progression-free survival (PFS)
As a primary clinical endpoint, the progression-free survival (PFS) of the patients in the observational cohort will be analyzed after two years.
Time frame
2 yearsSecondary outcomes
1
Locoregional recurrence rate (LRR)
Secondary clinical endpoints, the locoregional recurrence rate (LRR) after two and five years in the observational cohort will be addressed.
Time frame
From baseline to the end of study period, up to 5 years2
Occurrence of distant metastases
The occurrence of distant metastases after two and five years in the observational cohort will be addressed.
Time frame
From baseline to the end of study period, up to 5 years3
Longitudinal immunophenotyping of the patients: Detection of about 30 distinct immune cell (sub)types together with their activation markers during study period
The distribution of immune cells and messenger substances in the blood will be examined by means of immunophenotyping in order to add the systemic immune cell composition. Flow cytometric assessment of the amount of circulating immune cell-distribution per milliliter whole blood.
Time frame
Change of the immunophenotyping from baseline to the end of study period, up to 5 years4
Immune status of the resected tumor
The local immune status of the resected tumor is assessed by examining various immunological parameters during the pathological analysis of the tissue, which includes the expression of immune checkpoint molecules on the cells of the tumor microenvironment, such as PD1, its respective ligands or TIM3 and LAG3. Further, the infiltration of numerous of different immune cell populations in the tumor tissue will be examined, which includes CD19+ CD20+ B cells, CD4+ and CD8+ T cells or neutrophilic granulocytes.
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov