The prognostic role of tumor infiltrating T-lymphocytes in squamous cell carcinoma of the head and neck: A systematic review and meta-analysis.
Emma J de Ruiter, Marc L Ooft, Lot A Devriese...
https://pubmed.ncbi.nlm.nih.gov/29147608/Actively Recruiting
Led by University of Erlangen-Nürnberg Medical School · Updated on 2023-05-17
1100
Participants Needed
3
Research Sites
52 weeks
Total Duration
Researchers are studying the role of immune biomarkers both within tumors and in the bloodstream for people newly diagnosed with non-metastatic head and neck cancers such as squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, paranasal sinuses, or larynx. The goal is to understand how local immune activity in tumors relates to systemic immune status, to identify immune patterns that could help predict outcomes and guide future personalized treatments. This observational trial aims to create a prognostic score based on clusters of tumor immune characteristics. Participants include those with newly diagnosed head and neck squamous cell carcinoma in specific stages, as well as a control group of patients without cancer undergoing surgery. Blood, saliva, stool, and tumor tissue samples will be collected at various points, including before surgery, shortly after surgery, and during or after radiotherapy or immunotherapy. Tumor organoids will be grown outside the body for further biological analysis. During the study, patients will have multiple blood draws and other sample collections to monitor immune cell types, cytokines, gene activity, metabolic and microbiomic states over time, up to five years after treatment. Researchers will observe changes in the immune environment from before surgery through the end of radiotherapy and beyond. This long-term monitoring aims to correlate immune changes with patient outcomes and improve understanding of tumor-immune interactions.
CONDITIONS
Immune Biomarker Study for Head and Neck Cancer
A
Antoniu-Oreste Gostian, PD Dr. med.
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University of Erlangen-Nürnberg Medical School
Lead Sponsor
University Hospital Erlangen
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 5 years
Participants provide blood, saliva, sputum, stool, and tissue samples at specified time points for detailed immunomonitoring and biomarker analysis during and after treatment or surgery.
Visits at baseline (before surgery or treatment), day 7 after surgery, end of radiotherapy (day 60-80), and periodic visits up to 5 years
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/29754777/University of Erlangen-Nürnberg Medical School
Lead Sponsor
University Hospital Erlangen
Collaborating Sponsor