ongitudinal analysis of head and neck cancer-specific immunity in patients treated with (salvage) surgery

Completed

• Conditions: 10027656; 10019190; head and neck cancer; squamous cell carcinoma

• Registration Number: NL-OMON42765
• Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

a. Histologically proven HPV positive or negative HNSCC with an indication for (salvage) surgery with/without adjuvant (C)RT in a curative setting
b. Tumor site: oral cavity, and in case of salvage surgery: all sites
c. Age above 18 years
d. Performance score WHO 0,1 or 2 at time of study entry
e. Written ICF

Exclusion Criteria

a. The use of immunosuppressive drugs at start of the treatment
b. Anemia < 6.0 mmol/L
c. In case of disease relapse or progression: Any bleeding disorder or anti-coagulation therapy, that cannot be discontinued or corrected, that significantly increases the risk of a bleeding due to the biopsy.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>a. To assess the presence and functionality of tumor-specific T cells as<br /><br>potential target for immunotherapy.<br /><br>b. To find potential predictive and/or prognostic markers in biopsied tumor<br /><br>material and peripheral blood.<br /><br>c. To study the kinetics of tumor-specific T cell populations in the tumor and<br /><br>blood over time, and the effect of treatment on that.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>na</p><br>